Ascent Knee System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: Ascent Knee System FDA UDI
Generic Name: Tibial insert FDA UDI
Model / Reference: 179820 FDA UDI

Identifiers

Catalog Number: 179820 FDA UDI
Primary DI / UDI-DI: 00880304265295 FDA UDI
510(k) Number: K022586 FDA UDI
K171054 FDA UDI
FDA Product Code: JWH FDA UDI
HRY FDA UDI
MBV FDA UDI
MBH FDA UDI
OIY FDA UDI
GMDN Term: Tibial insert FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3530 FDA UDI
888.3565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Tibial insert

The Ascent Knee System is a high-quality, one-piece contoured polyethylene (PE) insert for the femoral and tibial components of a knee joint prosthesis. This device articulates during primary or revision bicondylar knee joint replacement, reproducing the flexion movement of the knee joint with its lateral rotation and anterior/posterior movement capabilities.

Similar devices

Also classified as Tibial insert.

DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
P.F.C. SIGMA — DEPUY (IRELAND) · Class II
Truliant, Activit-E — Exactech, Inc. · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
TriVerse Meniscal Insert PS+ — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Scorpio — Howmedica Osteonics Corp. · Class II
World Knee System — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
Optetrak Logic — Exactech, Inc. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI ca982ad9-b3d3-407d-9387-149907a771c2 36 fields · synced Jul 14, 2026