Cleared Traditional

K915617 - LSF HA COATED FEMORAL HIP

K915617 is an FDA 510(k) clearance for LSF HA COATED FEMORAL HIP, manufactured by Implant Technology, Inc.. The device is a Class 2 Orthopedic device with product code MEH cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K915617 · Implant Technology, Inc. · Orthopedic device
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May 1992
Decision
164d
Days
Class 2
Risk

K915617 is an FDA 510(k) clearance for the LSF HA COATED FEMORAL HIP. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Implant Technology, Inc. (Secaucus, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 164 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 Implant Technology, Inc. devices

FDA 510(k) Submission Details - K915617

510(k) Number K915617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1991
Decision Date May 28, 1992
Days to Decision 164 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 122d · This submission: 164d
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 156
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K915617.
HYDROXYLAPATITE INFINITY(R)
K920969 · Dow Corning Wright · May 1993
PERFECTA TOTAL HIP SYSTEM, HA COATED
K915190 · Orthomet, Inc. · Dec 1992
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
S-ROM ZT HA PROXIMAL FEMORAL SLEEVE
K912713 · Joint Medical Products Corp. · Dec 1991