Cleared Traditional

K920639 - RX 90 ACETABULAR COMPONENT SYSTEM

K920639 is an FDA 510(k) clearance for RX 90 ACETABULAR COMPONENT SYSTEM, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K920639 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
139d
Days
Class 2
Risk

K920639 is an FDA 510(k) clearance for the RX 90 ACETABULAR COMPONENT SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 30, 1992 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K920639

510(k) Number K920639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1992
Decision Date June 30, 1992
Days to Decision 139 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K920639.
MODULAR FEMORAL HEAD WITH OFFSET TRUNION
K914675 · Kirschner Medical Corp. · Aug 1992
ZIRCONIUM ALLOY FRMORAL HEAD
K914878 · Smith & Nephew Richards, Inc. · Jul 1992
MODULAR ACETABULAR CUP SYSTEM
K920430 · Smith & Nephew Richards, Inc. · Jul 1992
FULL HEMISPHERE RING-LOC LINER
K920640 · Biomet, Inc. · Jun 1992
PRECISION STRATA TOTAL HIP STEM
K921383 · Howmedica Corp. · Jun 1992
DEPUY TOTAL HIP BALLS - ION IMPLANTATION
K920286 · Depuy, Inc. · Apr 1992