Cleared Traditional

K870088 - S-ROM SUPERCUP ACETABULAR CUP

K870088 is an FDA 510(k) clearance for S-ROM SUPERCUP ACETABULAR CUP, manufactured by Joint Medical Products Corp.. The device is a Class 2 Orthopedic device with product code LWJ cleared through the Traditional 510(k) pathway after a 469-day FDA review.

K870088 · Joint Medical Products Corp. · Orthopedic device
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Apr 1988
Decision
469d
Days
Class 2
Risk

K870088 is an FDA 510(k) clearance for the S-ROM SUPERCUP ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (product code LWJ), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on April 22, 1988 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Joint Medical Products Corp. devices

FDA 510(k) Submission Details - K870088

510(k) Number K870088 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 09, 1987
Decision Date April 22, 1988
Days to Decision 469 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
347d slower than avg
Panel avg: 122d · This submission: 469d
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 62
Devices cleared under the same product code (LWJ) and FDA review panel - the closest regulatory comparables to K870088.
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921 · Osteonics Corp. · Oct 1988
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
K881983 · Howmedica Corp. · Oct 1988
CORIN MODULAR MOORE STEM
K881288 · Orthopedic Systems, Inc. · Jun 1988
TI-FIT TOTAL HIP SYSTEM
K873797 · Richards Medical Co., Inc. · Nov 1987
MICRO-STRUCTURED HS2P HIP STEMS
K833970 · Osteonics Corp. · Jan 1984