SYNTHES (U.S.A.) POLYPIN

K961608 · Synthes (Usa) · HTY · May 9, 1997 · Orthopedic

Device Facts

• Record ID: K961608
• Device Name: SYNTHES (U.S.A.) POLYPIN
• Applicant: Synthes (Usa)
• Product Code: HTY · Orthopedic
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Polypin is intended for use in the fixation of small bone fragments in cases of low-load fractures, such as apical fragments, osteochondral fragments and cancellous/non-load-bearing fragments. Specific applications include the following: Apical fragments: radial head, patellar rim, navicular, metacarpal/metatarsal (proximal or distal ends) Osteochondral fragments: talus vault, femoral condyle Spongy/non-load bearing fragments: talus

Device Story

Absorbable bone fixation pin; 2 mm diameter; 35 mm length (trimmable to 10 mm). Material: high molecular weight poly (L/D-lactide). Design features: eleven ring-shaped ribs for anti-migration; lens-shaped head for sub-surface implantation. Used by orthopedic surgeons in clinical settings for low-load bone fragment compression. Device provides temporary fixation; absorbs over time; eliminates need for secondary removal surgery. Presterilized via gamma radiation.

Clinical Evidence

Extensive in-vitro and in-vivo testing performed. No specific clinical trial data or metrics provided in the summary.

Technological Characteristics

Material: high molecular weight absorbable poly (L/D-lactide). Dimensions: 2 mm diameter, 35 mm length (trimmable). Features: 11 ring-shaped ribs, lens-shaped head. Sterilization: gamma radiation.

Indications for Use

Indicated for patients requiring fixation of small bone fragments in low-load fracture scenarios, including apical, osteochondral, and cancellous/non-load-bearing fragments in areas such as the radial head, patellar rim, navicular, metacarpal/metatarsal, talus vault, and femoral condyle.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Kirschner wires
• Small screws
• Johnson & Johnson OrthoSorb Absorbable Pin
• Biosciences, Inc. BIOFIX Bioabsorbable Pin

Submission Summary (Full Text)

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SYNTHES
MAY - 9 1997

# Attachment II: SUMMARY OF SAFETY AND EFFECTIVENESS FOR SYNTHES (U.S.A.) POLYPIN

1c961608

## 1. SPONSOR NAME AND ADDRESS

Synthes (U.S.A.)
P.O. Box 1766
1690 Russell Road
Paoli, PA 19301
TEL: [phone]

Contact Person:
Angela Silvestri
Manager, Regulatory Affairs

## 2. DEVICE NAME

Common/Usual Name: Bone Fixation Pin
Proprietary Name: Synthes (U.S.A.) Polypin

## 3. CLASSIFICATION

Bone Fixation Pins have been classified as Class II Orthopedic Devices under 21 CFR 888.3030.

## 4. INTENDED USE

The Polypin is intended for use in the fixation of small bone fragments in cases of low-load fractures, such as apical fragments, osteochondral fragments and cancellous/non-load-bearing fragments. Specific applications include the following:

**Apical fragments:**
- radial head
- patellar rim
- navicular
- metacarpal/metatarsal (proximal or distal ends)

**Osteochondral fragments:**
- talus vault
- femoral condyle

**Spongy/non-load bearing fragments:**
- talus

## 5. DEVICE DESCRIPTION

The Polypin is a 2 mm diameter pin of high molecular weight absorbable poly (L/D-lactide). The Polypin is provided with a length of 35 mm, which can be shortened intraoperatively to as little as 10 mm. Eleven ring-shaped ribs, placed

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SYNTHES

at intervals of 2.5 mm on the pin, prevent the implanted pin from slipping out. The small, lens-shaped head of the Polypin permits the pin to be pushed down until it is completely below the surface of the cartilage or bone, permitting low load compression of the bone fragments. The Polypin is provided presterilized by gamma radiation and is not intended to be resterilized by the user.

## 6. SUBSTANTIAL EQUIVALENCE

The Polypin is substantially equivalent to preamendment, Class II metallic implants, such as Kirschner wires and small screws, used for the fixation of bony fragments. The Polypin is also substantially equivalent to other absorbable bone pins, such as the Johnson & Johnson OrthoSorb® Absorbable Pin, made of polydioxanon, and the Biosciences, Inc. BIOFIX® Bioabsorbable Pin, made of self-reinforced polyglycolide.

The determination of substantial equivalence was based on extensive in-vitro and in-vivo testing of the Polypin.