Cleared Traditional

S-ROM OBLONG ACETABULAR CUP (K905258) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905258 · Joint Medical Products Corp. · Orthopedic device
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May 1991
Decision
181d
Days
Class 2
Risk

K905258 is an FDA 510(k) clearance for the S-ROM OBLONG ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on May 21, 1991 after a review of 181 days - an extended review cycle.

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 Joint Medical Products Corp. devices

Submission Details

510(k) Number K905258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1990
Decision Date May 21, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 122d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 282
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K905258.
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP
K911685 · Biomet, Inc. · Jul 1991
BIOMET COBALT-CHROME FEMORAL COMPONENTS
K911684 · Biomet, Inc. · Jun 1991
HOWMEDICA(R) CEMETED FEMORAL COMPONENT
K910869 · Howmedica Corp. · May 1991
PS OMNIFIT NORMALIZED HIP STEM SERIES
K910662 · Osteonics Corp. · May 1991
OSTEONICS CDH HIP STEM
K910922 · Osteonics Corp. · Apr 1991
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES
K910988 · Osteonics Corp. · Mar 1991