Libertas E-XLPE Modular Liner

Q: What is the product code of K192989?

The FDA product code is OQI – Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.

FDA 510(k) K192989 · Maxx Orthopedics, Inc.

Substantially Equivalent

510(k) numberK192989

Submission

Device name: Libertas E-XLPE Modular Liner
Applicant: Maxx Orthopedics, Inc.
Norristown, PA, US
Received: October 25, 2019
Decision date: October 29, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OQI – Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3353
Specialty: Orthopedic
Implant: Yes

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 the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and…

Other 510(k)s with product code OQI

510(k)	Device	Applicant	Decision
K252451	EPORE® XO cup systemOQI · Traditional	Implantcast GmbH	04/24/2026SE
K172833	E-XPE Acetabular Components and U-Motion II Acetabular CupOQI · Traditional	United Orthopedic Corporation	06/12/2018SE
K173583	Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersOQI · Traditional	Exactech, Inc.	03/12/2018SE
K111481	Corin Trinity Acetabular System Ecima LinersOQI · Traditional	Corin USA	02/06/2012SE

More from Corin USA

510(k)	Device	Decision
K261563	Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional	08/07/2026SE
K261609	Freedom Partial Knee SystemHSX · Traditional	08/04/2026SE
K253171	Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional	01/15/2026SE
K252777	Freedom Metaphyseal Cone Implants (Metaphyseal Cones)MBH · Traditional	10/31/2025SE
K253314	Freedom Infinia Total Knee SystemJWH · Special	10/29/2025SE
K253144	Freedom® Total Knee System Titan PCK ComponentsJWH · Special	10/22/2025SE
K243634	Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY · Traditional	08/25/2025SE
K251717	Freedom® Total Knee System Titanium Tibial Base PlateJWH · Special	06/26/2025SE
K250382	Freedom Total Knee System (All-poly Tibial Plate)JWH · Special	03/13/2025SE
K241597	Freedom® Total Knee System - Porous Tibial Base PlateMBH · Traditional	02/13/2025SE

Questions and answers

When was Libertas E-XLPE Modular Liner cleared by the FDA?

Libertas E-XLPE Modular Liner (K192989) received a 510(k) decision of Substantially Equivalent on October 29, 2020, 370 days after the submission was received.

What is the product code of K192989?

The FDA product code is OQI – Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.