(379 days)
The Polypin is intended for use in the fixation of small bone fragments in cases of lowload fractures, such as apical fragments, osteochondral fragments and cancellous/nonload-bearing fragments. Specific applications include the following:
| Apical fragments: | radial headpatellar rimnavicularmetacarpal/metatarsal (proximal or distal ends) |
|---|---|
| Osteochondral fragments: | talus vaultfemoral condyle |
| Spongy/non-load bearingfragments: | talus |
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 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.
It appears the provided text describes a medical device (SYNTHES (U.S.A.) POLYPIN) and its characteristics, intended use, and substantial equivalence to other devices. However, the document does not contain information about acceptance criteria, device performance testing against those criteria, or details regarding a study to prove the device meets acceptance criteria as requested in the prompt.
Therefore, I cannot extract the information to populate the requested table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established.
The "substantial equivalence" section mentions "extensive in-vitro and in-vivo testing," but it does not provide any results, acceptance criteria, or details about these tests.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. The logo appears to be a head with a halo above it, sitting on top of a cup-shaped base. A small circle with a "degree" symbol is located to the upper right of the letter "S" in the word "SYNTHES".
Attachment II: SUMMARY OF SAFETY AND EFFECTIVENESS FOR SYNTHES (U.S.A.) POLYPIN
SPONSOR NAME AND ADDRESS 1.
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
in DEVICE NAME
Common/Usual Name: Bone Fixation Pin
Proprietarv Name: Synthes (U.S.A.) Polypin
3. CLASSIFICATION
Bone Fixation Pins have been classified as Class II Orthopedic Devices under 21 CFR 888.3030.
INTENDED USE 4.
The Polypin is intended for use in the fixation of small bone fragments in cases of lowload fractures, such as apical fragments, osteochondral fragments and cancellous/nonload-bearing fragments. Specific applications include the following:
| Apical fragments: | radial headpatellar rimnavicularmetacarpal/metatarsal (proximal or distal ends) |
|---|---|
| Osteochondral fragments: | talus vaultfemoral condyle |
| Spongy/non-load bearingfragments: | 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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Image /page/1/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. A small circle with the registered trademark symbol is located to the right of the word.
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.
SUBSTANTIAL EQUIVALENCE Q.
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.