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510(k) Data Aggregation
K Number
K233592Device Name
BioPoly Radial Head Implant
Manufacturer
BioPoly, LLC
Date Cleared
2024-03-13
(126 days)
Product Code
KWI
Regulation Number
888.3170Why did this record match?
Applicant Name (Manufacturer) :
BioPoly, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioPoly Radial Head Implant is indicated for:
- · Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain. crepitation, and decreased motion at the radio-humeral and or proximal radio-ulnar joint with:
- o joint destruction and/or subluxation visible on x-ray; and/or
- o resistance to conservative treatment
- · Primary replacement after fracture of the radial head
- · Symptomatic sequelae after radial head resection
- · Revision following failed radial head arthroplasty
Device Description
The BioPoly Radial Head Implant is a hemiarthroplasty device designed to restore the articular surface and spacing of the proximal head of the radius in patients following fracture resection and/or degenerative disability The implant is supplied with head diameters of 20mm, 23mm, and 26mm; and stem diameters of 6mm, 7mm, 8mm, +3mm, and +6mm height offsets for the radius in patients following fracture, resection, and/or degenerative disability.
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K Number
K222964Device Name
BioPoly Lesser Toe Hemiarthroplasty Implant
Manufacturer
BioPoly, LLC
Date Cleared
2022-11-22
(56 days)
Product Code
KWD
Regulation Number
888.3730Why did this record match?
Applicant Name (Manufacturer) :
BioPoly, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioPoly Lesser Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface in patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
Device Description
The BioPoly Lesser Toe Hemiarthroplasty Implant is a hemiarthroplasty device specifically designed to restore the articular surface of the lesser metatarsal bones in patients with degenerative and post-traumatic arthritis.
The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6A1-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.
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K Number
K203634Device Name
BioPoly Great Toe Hemiarthroplasty Implant
Manufacturer
BioPoly, LLC
Date Cleared
2021-02-02
(53 days)
Product Code
KWD
Regulation Number
888.3730Why did this record match?
Applicant Name (Manufacturer) :
BioPoly, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the presence of good bone stock along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
Device Description
The BioPoly Great Toe Hemiarthroplasty Implant is a hemi-arthroplasty device specifically designed to restore the articular surface of the first metatarsal bone in patients with degenerative and post-traumatic arthritis.
The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6Al-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.
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