← Product Code [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY) · K961608 # SYNTHES (U.S.A.) POLYPIN (K961608) _Synthes (Usa) · HTY · May 9, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K961608 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [HTY](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY.md) - **Decision Date:** May 9, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## 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 ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: (610) 647-9700 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 {1} 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. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K961608](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HTY/K961608) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com