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The Tracker / January 2026 / K253171

510(k) cleared

Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

Maxx Orthopedics, Inc. · Jan 15, 2026 · K253171

FDA cleared the Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) from Maxx Orthopedics, Inc. on Jan 15, 2026 under K253171, a traditional 510(k). The device falls under product code LZO, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, regulated at 21 CFR 888.3353 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Sep 26, 2025. The decision came 111 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Maxx Orthopedics, Inc. has 4 other decisions in the tracker over the last 12 months: K261563 (Freedom Total Knee System (E-Poly Tibial Liners)), K252777 (Freedom Metaphyseal Cone Implants (Metaphyseal Cones)), K253314 (Freedom Infinia Total Knee System), K253144 (Freedom® Total Knee System Titan PCK Components).

Questions & Answers

What did FDA clear under K253171?

K253171 is the FDA 510(k) for Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem), submitted by Maxx Orthopedics, Inc.. FDA's decision date was Jan 15, 2026, under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

Who makes the Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)?

Maxx Orthopedics, Inc., based in Norristown, PA, is the applicant of record for K253171.

How long did the K253171 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jan 15, 2026, 111 days later.

← All decisions in January 2026

Sources