Cleared Traditional

K900262 - ACSYS SELFTAP ACETABULAR CUP PROSTHESIS

K900262 is an FDA 510(k) clearance for ACSYS SELFTAP ACETABULAR CUP PROSTHESIS, manufactured by 3M Company. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K900262 · 3M Company · Orthopedic device
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Sep 1990
Decision
240d
Days
Class 2
Risk

K900262 is an FDA 510(k) clearance for the ACSYS SELFTAP ACETABULAR CUP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on September 14, 1990 after a review of 240 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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: Standard predicate-based submission. Standard predicate reliance. 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 3M Company devices

FDA 510(k) Submission Details - K900262

510(k) Number K900262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date September 14, 1990
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWJ Device Classification - Class 2, Special Controls

Product Code LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LWJ Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented

All 57
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K900262.
HOWMEDICA HNR SYSTEM
K903563 · Howmedica Corp. · Mar 1991
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
K905254 · Depuy, Inc. · Feb 1991
GERI TOTAL HIP SYSTEM
K905186 · Smith & Nephew Richards, Inc. · Feb 1991
ACSYS SHEARER ACETABULAR CUP PROSTHESIS
K900435 · 3M Company · Sep 1990
KDR ACETABULAR COMPONENT
K895702 · Osteonics Corp. · Nov 1989
FREEMAN TOTAL HIP SYSTEM RIDGED STEM
K890331 · Orthopedic Systems, Inc. · Oct 1989