Cleared Traditional

K912713 - S-ROM ZT HA PROXIMAL FEMORAL SLEEVE

K912713 is an FDA 510(k) clearance for S-ROM ZT HA PROXIMAL FEMORAL SLEEVE, manufactured by Joint Medical Products Corp.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K912713 · Joint Medical Products Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
193d
Days
Class 2
Risk

K912713 is an FDA 510(k) clearance for the S-ROM ZT HA PROXIMAL FEMORAL SLEEVE. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Joint Medical Products Corp. (Stamford, US). The FDA issued a Cleared decision on December 30, 1991 after a review of 193 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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

FDA 510(k) Submission Details - K912713

510(k) Number K912713 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 20, 1991
Decision Date December 30, 1991
Days to Decision 193 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
71d slower than avg
Panel avg: 122d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEH Device Classification - Class 2, Special Controls

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 134
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K912713.
INTER-HA HIP PROSTHESIS
K921672 · Kirschner Medical Corp. · Aug 1992
KINAMED ATH-HA & ATH-HA LONG TOTAL HIP
K914843 · Kinamed, Inc. · Feb 1992
HYDROXYAPATITE INFINITY TROCHANTERIC MODULE
K915350 · Dow Corning Wright · Feb 1992
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
K913916 · Smith & Nephew Richards, Inc. · Dec 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
K912369 · Biomet, Inc. · Oct 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · Biomet, Inc. · Oct 1991