K-number	K253171
Device name	Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
Applicant	Maxx Orthopedics, Inc.
Product code	LZO
Device class	Class II
Decision date	Jan 15, 2026
Decision	Substantially Equivalent
Regulation	888.3353

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Libertas Taper Short (TS) Uncemented Femoral Stem is a hip replacement component made of titanium alloy for use in total hip arthroplasty. It is intended to restore patient mobility and reduce pain in patients with degenerative joint disease, arthritis, hip dysplasia, fractures, and other conditions affecting the hip joint.

Technological characteristics

The subject device has the same geometry as the predicate Libertas Taper Uncemented Femoral Stem (K183684) but with modifications to the anterior/posterior size to create a larger proximal cross-section for more proximal filling. The lengths, neck angles, offsets, curvature, sizing, titanium plasma spray coating, and trunnion taper features are identical to the predicate device.

Test standards cited

ISO 7206-6 and 7206-4 for fatigue testing; ISO 25135 for range of motion and impingement evaluation; ASTM F1875 for fretting corrosion testing of the femoral head and stem taper interface.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

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

Everything you need for a 510(k) submission. Nothing you don't.