510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192989Substantially Equivalent

Libertas E-XLPE Modular Liner

Maxx Orthopedics Inc., Norristown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192989 is the FDA 510(k) clearance record for Libertas E-XLPE Modular Liner, a class II device, cleared for Maxx Orthopedics, Inc. on under FDA product code OQI (Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented). FDA's definition for product code OQI reads: "1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of...". FDA records list 25 510(k) clearances for Maxx Orthopedics, Inc., from to . As of , FDA records show no recalls naming K192989.

Clearance record

Decision date
Received
(370 days to decision)
Product code
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Regulation
21 CFR 888.3353
Device class
Class II
Review panel
Orthopedic
Applicant
Maxx Orthopedics, Inc. 2460 General Armistead Ave. Suite 100, Norristown PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OQI

Trailing 12 months
1 clearance under product code OQI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OQI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260