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PDS Flexible Plates

PDS Flexible Plates are thin, bendable sheets used mainly in facial or cranial surgeries to help support and shape healing bones or soft tissues.

“PDS” stands for Polydioxanone, which is a biodegradable polymer. This means it slowly dissolves in the body over time, so there’s no need to remove it later with another surgery.

Unlike metal plates (like titanium mesh), PDS flexible plates are soft and flexible, making them useful for delicate areas, especially in children or in areas like the nose, eye sockets, or jaw.


They are often trimmed and shaped during surgery to fit the specific area.

In simple terms:
PDS Flexible Plates are like soft, dissolvable bandages made of special plastic that help bones and tissues in the face heal properly. They are safe, don’t need to be taken out later, and are gentler than metal plates.

How do PDS plates work, and how long do they stay in the body?

The image shows the packaging of an Ethicon™ PDS™ Flexible Plate, a medical device commonly used in craniofacial and reconstructive surgeries. Here's a detailed description of what's on the label:
The Image shows the packaging of an Ethicon™ PDS™ Flexible Plate, a medical device commonly used in craniofacial and reconstructive surgeries. Here’s a detailed description of what’s on the label:

PDS plates are ultra‑thin, bioabsorbable sheets crafted from the same polydioxanone polymer as PDS™ sutures. In procedures like septorhinoplasty or orbital‑floor reconstruction, they’re anchored temporarily to support and reshape cartilage or soft bone.

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While in place, they provide mechanical reinforcement and a scaffold that promotes new tissue growth. As healing advances, they slowly hydrolyze, transferring the load to the regenerated tissue until the plate is completely absorbed.

AdvantagesDisadvantages
Absorbable – No need for removal surgeryLess strong than metal plates (e.g., titanium)
PDS flexible plates, septal reconstruction implant
PDS flexible plates, septal reconstruction implant
Flexible – Easily shaped to fit complex areasMay lose strength before full healing occurs
Biocompatible – Low risk of rejectionNot suitable for high-load bearing areas
Reduces long-term foreign material in bodyCan be more expensive than some permanent options
Ideal for pediatric use or growing bonesLimited use in very complex or large fractures
Helps avoid growth problems in childrenMay degrade faster in some body environments
Reduces risk of long-term infectionMay not be visible on X-rays once absorbed

Table outlining the advantages and disadvantages of PDS Flexible Plates.

Pros and Cons of PDS Flexible Cranial Plates

An image of PDS Flexible Plate in its package.
An Image of PDS Flexible Plate in its package.
Pros in Surgery Cons in Surgery
Absorbable – avoids second surgery to remove plateLimited mechanical strength – not ideal for load-bearing areas
Flexible – easy to trim and shape during surgeryDegradation timeline may not match bone healing in all cases
Biocompatible – reduces inflammation and rejectionNot suitable for complex or large fractures
Ideal for pediatric surgeries – supports growing bonesRequires precise placement to avoid early degradation
Minimizes long-term foreign body presenceMay not provide enough long-term support in adults
Useful in delicate facial and cranial areasReduced visibility in imaging once absorbed

PDS Flexible Plates are made from

  • Made from polydioxanone (PDS) – a biodegradable polymer used in dissolvable sutures.
  • Flexible because of its soft, plastic-like structure (not metal).
  • Composed of a polymer matrix – chains of molecules that allow bending without breaking.
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PDS polymer fixation plate
PDS polymer fixation plate
  • Can be warmed and shaped during surgery to fit the surgical site.
  • Holds its shape once cooled, providing temporary support.
  • Gradually absorbed by the body over time, eliminating the need for removal.
  • Non-metallic – unlike memory alloys like nitinol, it doesn’t have shape memory but remains moldable.
  • Safe and biocompatible, ideal for delicate or growing tissue (e.g., in children).
  • Polydioxanone (PDS):
    • A synthetic polymer made from p-dioxanone monomers.
    • It is the primary and only active material in PDS plates.
    • Belongs to the polyester family of polymers.
    • Known for being biodegradable, absorbable, and biocompatible.

👉 No metal, no memory alloy, and no mixed materials.
👉 It is manufactured in a sterile, medical-grade form for surgical use.

PDS Flexible Cranial Plate Use in Septo-Rhinoplasty

Preparation For PDS Flexible PLATES

Step by Step Preparation of PDS flexible Plates
Step by Step Preparation of PDS flexible Plates

Ready for Use When:

  • Properly sized and shaped.
  • Softened if needed.
  • Maintains sterility throughout preparation.
Ethicon PDS™ Flexible Plate
Polydioxanone bioabsorbable implant
Resorbable fixation plate
Perforated polymer surgical plate
0.15 × 50 × 40 mm PDS plate
Ethicon PDS™ Flexible Plate
Polydioxanone bioabsorbable implant
Resorbable fixation plate
Perforated polymer surgical plate
0.15 × 50 × 40 mm PDS plate

Special post‑op care or activity restriction required when using PDS plates?

RecommendationDuration
Wound care
• Keep incision sites clean and dry
• Change dressings as instructed
Until sutures are removed (≈7–10 days)
Head elevation
• Sleep with head elevated (pillows or recliner) to reduce swelling
First 5–7 days
Cold compresses

• Apply cold packs (wrapped) 10 min on / 10 min off to lessen bruising/swelling
First 48 hours
Strenuous activity

• No heavy lifting, bending, or vigorous exercise
2–3 weeks
Facial movements
• Avoid blowing your nose, wide yawning, or chewing very hard
1–2 weeks
Contact sports
• No helmets, goggles, or any direct‑impact activities
6–8 weeks
Medications
• Take prescribed antibiotics and pain relievers as directed
As prescribed
Follow‑up visits
• Attend post‑op checkups to monitor healing and plate absorption
Surgeon’s schedule

Tip: Always follow your surgeon’s specific instructions—individual healing times and restrictions can vary.

6 Medical Conditions PDS Plate is Use for

Septorhinoplasty & Nasal Septum Reconstruction
Serve as a scaffold to reinforce columellar struts, L‑struts, septal extension grafts and to reconstruct or reshape the nasal septum in cosmetic and functional rhinoplasty procedures.

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Alar Batten & Lateral Crural Strut Grafts
Support weak lower‑lateral (alar) cartilages by creating batten grafts or lateral crural struts, enhancing tip projection and contour without harvesting additional autologous tissue.

Nasal Septal Perforation Repair
Act as an underlay or overlay scaffold—often combined with fascia grafts—to close septal perforations and promote mucosal healing, achieving high closure rates with minimal complications.

Nasoseptal Fracture (Open Septal Reduction)
Used as an internal stent to reinforce and realign fractured septal cartilage in open reduction of septal fractures, improving stability and contour during healing.

Perforated polymer surgical plate
Perforated polymer surgical plate

Endoscopic Skull Base & CSF Leak Repair
Provide a rigid, bioabsorbable barrier for multilayer closure of skull‑base defects (e.g., encephaloceles or cerebrospinal fluid leaks) via endonasal endoscopic approaches.

General Maxillofacial & Plastic Surgery Reconstruction
Employed to reinforce thin cartilage or bone frameworks in facial contour corrections (e.g., orbital floor, malar augmentation) and other craniomaxillofacial procedures, offering temporary support before gradual resorption.

Contraindications (Who Should NOT Use PDS Flexible Plates):

DS Flexible Plates are generally safe, but they are not suitable for everyone or every surgical situation. Here’s a list of who should not use them:


🚫 1. Patients with Heavy Load-Bearing Needs

  • Not suitable for areas that require strong mechanical support (e.g., jaw reconstruction, weight-bearing cranial bones).
  • PDS is not as strong as metal plates and can degrade before full healing in high-stress zones.

🚫 2. Severe or Complex Fractures

  • In cases with large or comminuted fractures, especially in the orbit or midface, the plate may not provide enough long-term support.

🚫 3. Allergy or Sensitivity to Polymers

  • Although rare, patients with known allergies to synthetic absorbable polymers (polydioxanone) should avoid use.

🚫 4. Poor Wound Healing or Infections

  • Not recommended in infected surgical fields or where tissue healing is compromised (e.g., radiation damage, poor blood supply).

🚫 5. Adults Needing Permanent Structural Support

  • Because PDS is absorbable, it may not be appropriate in older adults or those who require permanent fixation.

🚫 6. Areas Requiring Radiographic Visibility

  • Once absorbed, the plate cannot be seen on X-rays, which may be a drawback in follow-up imaging or trauma assessment.
PDS flexible plates, polydioxanone resorbable plate
PDS flexible plates, polydioxanone resorbable plate

Absorption Time of PDS Flexible Plate (Polydioxanone)

  • Initial strength retention:
    • Around 70% at 2 weeks,
    • 50% at 4 weeks,
    • Drops significantly by 6 weeks.
  • Complete absorption:
    • Typically occurs within 6 months (approximately 180 days).
    • Absorption happens through hydrolysis (breaking down in the presence of body fluids).

✅ PDS Flexible Plates provide temporary support for healing tissues, then gradually dissolve within 6 months, reducing the risk of long-term foreign body complications.

A table showing the Absorption of PDS plate by weeks
A table showing the Absorption of PDS plate by weeks

FDA Approval:

  • Regulated as a Class II medical device under the FDA.
  • Listed in the FDA’s Global Unique Device Identification Database (GUDID) under Ethicon (a Johnson & Johnson company).
  • Labeled for absorbable internal use in soft tissue and bone support, especially in craniofacial reconstruction.

CE Mark (Europe):

  • PDS plates distributed in Europe carry a CE mark, meaning they meet the EU’s Medical Device Regulation (MDR) standards.
  • They are certified for use in craniofacial, nasal, and orbital repairs in both pediatric and adult populations.

Is PDS plates an Implant

Yes. PDS (polydioxanone) plates are indeed surgical implants—specifically, they’re bio‑absorbable fixation plates rather than temporary surgical tools.

Made from a resorbable polymer (polydioxanone), they are shaped and secured in place (for example, to reinforce septal cartilage or reconstruct orbital floors), provide structural support for several months, and then gradually hydrolyze and are absorbed by the body over the following 6–12 months

Resources

https://primismedical.com/products

https://fda.report/GUDID/20705031132532

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=15614460&pc=


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