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.

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:

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.

Table of Contents

Advantages and Disadvantages of PDS Cranial Flexible Plates

Advantages	Disadvantages

Absorbable – No need for removal surgery

Less strong than metal plates (e.g., titanium)

Flexible – Easily shaped to fit complex areas

May lose strength before full healing occurs

Biocompatible – Low risk of rejection

Not suitable for high-load bearing areas

Reduces long-term foreign material in body

Can be more expensive than some permanent options

Ideal for pediatric use or growing bones

Limited use in very complex or large fractures

Helps avoid growth problems in children

May degrade faster in some body environments

Reduces risk of long-term infection

May 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 plate	Limited mechanical strength – not ideal for load-bearing areas
Flexible – easy to trim and shape during surgery	Degradation timeline may not match bone healing in all cases
Biocompatible – reduces inflammation and rejection	Not suitable for complex or large fractures
Ideal for pediatric surgeries – supports growing bones	Requires precise placement to avoid early degradation
Minimizes long-term foreign body presence	May not provide enough long-term support in adults
Useful in delicate facial and cranial areas	Reduced 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.
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).

Ingredients (Material Composition) of PDS Flexible Plates:

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*

Ready for Use When:

Properly sized and shaped.
Softened if needed.
Maintains sterility throughout preparation.

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.

⏳ 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.

✅ 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.

🔗 Example GUDID listing (for ZFP8 plate):
https://fda.report/GUDID/20705031132532

✅ 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.