Cleared Traditional

K903957 - VSP HIP STEM

K903957 is an FDA 510(k) clearance for VSP HIP STEM, manufactured by Turnkey Intergration USA, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K903957 · Turnkey Intergration USA, Inc. · Orthopedic device
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Nov 1990
Decision
90d
Days
Class 2
Risk

K903957 is an FDA 510(k) clearance for the VSP HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 26, 1990 after a review of 90 days - within the typical 510(k) review window.

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 Turnkey Intergration USA, Inc. devices

FDA 510(k) Submission Details - K903957

510(k) Number K903957 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 28, 1990
Decision Date November 26, 1990
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

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 465
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K903957.
OSTEONICS HIP REVISION WEDGES
K905406 · Osteonics Corp. · Jan 1991
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
K904844 · Howmedica Corp. · Dec 1990
PROXIMAL FEMUR REPLACEMENT STEM
K904919 · Depuy, Inc. · Dec 1990
PERFECTA TOTAL HIP SYSTEM
K903635 · Orthomet, Inc. · Nov 1990
OSTEONICS DRM ACETABULAR COMPONENT
K903636 · Osteonics Corp. · Oct 1990
OSTEOLOCK(TM) ACETABULAR CUP
K903362 · Howmedica Corp. · Oct 1990