Cleared Traditional

K870271 - S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP (FDA 510(k) Clearance)

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

K870271 · Joint Medical Products Corp. · Orthopedic device
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Apr 1987
Decision
88d
Days
Class 2
Risk

K870271 is an FDA 510(k) clearance for the S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP. Classified as Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (product code KWZ), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Washington, US). The FDA issued a Cleared decision on April 20, 1987 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3310 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Joint Medical Products Corp. devices

Submission Details

510(k) Number K870271 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 22, 1987
Decision Date April 20, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3310
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.