Cleared Traditional

K940297 - UNIVERSAL WRIST

K940297 is an FDA 510(k) clearance for UNIVERSAL WRIST, manufactured by Turnkey Intergration USA, Inc.. The device is a Class 2 Orthopedic device with product code JWI cleared through the Traditional 510(k) pathway after a 381-day FDA review.

K940297 · Turnkey Intergration USA, Inc. · Orthopedic device
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Feb 1995
Decision
381d
Days
Class 2
Risk

K940297 is an FDA 510(k) clearance for the UNIVERSAL WRIST. Classified as Prosthesis, Wrist, 2 Part Metal-plastic Articulation, Semi-constrained (product code JWI), Class II - Special Controls.

Submitted by Turnkey Intergration USA, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 6, 1995 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3800 - 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. Elevated predicate reliance profile. 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 - K940297

510(k) Number K940297 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 21, 1994
Decision Date February 06, 1995
Days to Decision 381 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
259d slower than avg
Panel avg: 122d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWI Device Classification - Class 2, Special Controls

Product Code JWI Prosthesis, Wrist, 2 Part Metal-plastic Articulation, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3800
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.