(379 days)
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No
The device description and intended use focus on a physical implantable pin made of absorbable polymer. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on in-vitro and in-vivo testing of the physical device.
Yes
The device description states that it is used in the "fixation of small bone fragments in cases of low load fractures," which is a medical treatment.
No
The device description clearly states "The Polypin is intended for use in the fixation of small bone fragments". This is a therapeutic function, not a diagnostic one.
No
The device description clearly states the Polypin is a physical pin made of absorbable poly (L/D-lactide) and is provided presterilized. This indicates it is a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of small bone fragments in cases of lowload fractures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical pin made of absorbable material, designed for implantation into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose (bone fixation).
N/A
Intended Use / Indications for Use
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 head
patellar rim
navicular
metacarpal/metatarsal (proximal or distal ends) |
|---|---|
| Osteochondral fragments: | talus vault
femoral condyle |
| Spongy/non-load bearing
fragments: | talus |
Product codes
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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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
radial head, patellar rim, navicular, metacarpal/metatarsal (proximal or distal ends), talus vault, femoral condyle, talus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence was based on extensive in-vitro and in-vivo testing of the Polypin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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 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
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.