Cleared Traditional

K902111 - MODIFIED FREEMAN REVISION ACETABULAR CUP

K902111 is an FDA 510(k) clearance for MODIFIED FREEMAN REVISION ACETABULAR CUP, manufactured by Turnkey Intergration USA, Inc.. The device is a Class 3 Orthopedic device with product code KWA cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K902111 · Turnkey Intergration USA, Inc. · Orthopedic device
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Aug 1990
Decision
105d
Days
Class 3
Risk

K902111 is an FDA 510(k) clearance for the MODIFIED FREEMAN REVISION ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by Turnkey Intergration USA, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Turnkey Intergration USA, Inc. devices

FDA 510(k) Submission Details - K902111

510(k) Number K902111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1990
Decision Date August 22, 1990
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

KWA Device Classification - Class 3, Premarket Approval

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 98
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K902111.
METAL ON METAL ACETABULAR SYSTEM
K993438 · Biomet, Inc. · May 2000
INTER-OP METASUL ACETABULAR SYSTEM
K974728 · Sulzer Orthopedics, Inc. · Aug 1999
MODIFIED FREEMAN ACETABULAR CUP
K902110 · Turnkey Intergration USA, Inc. · Aug 1990
SAMUELSON SCREWLOC CUP
K882671 · Protek, Inc. · Oct 1988
ATH METAL:UHMWPE TOTAL HIP SYSTEM
K882675 · Kinamed, Inc. · Aug 1988
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · Osteonics Corp. · Jan 1988