Cleared Traditional

K911058 - TECHMEDICA CAD/CAM CUSTOM HIP

K911058 is an FDA 510(k) clearance for TECHMEDICA CAD/CAM CUSTOM HIP, manufactured by Techmedica, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 718-day FDA review.

K911058 · Techmedica, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
718d
Days
Class 2
Risk

K911058 is an FDA 510(k) clearance for the TECHMEDICA CAD/CAM CUSTOM HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Techmedica, Inc. (Camarillo, US). The FDA issued a Cleared decision on February 23, 1993 after a review of 718 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Techmedica, Inc. devices

FDA 510(k) Submission Details - K911058

510(k) Number K911058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date February 23, 1993
Days to Decision 718 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
596d slower than avg
Panel avg: 122d · This submission: 718d
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 K911058.
STABILITY HIP FEMORAL COMPONENT
K915594 · Depuy, Inc. · Apr 1993
RMHS MONOLITHIC FEMORAL COMPONENT
K923275 · Smith & Nephew Richards, Inc. · Apr 1993
PERFECTA TOTAL HIP SYSTEM
K922847 · Orthomet, Inc. · Apr 1993
THE UNIVERSAL BONE CEMENT RESISTOR
K924323 · Biodynamic Technologies, Inc. · Feb 1993
PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP
K922733 · Orthomet, Inc. · Feb 1993
DEPUY HIP PROSTHESIS
K914078 · Depuy, Inc. · Jan 1993