Cleared Traditional

K895145 - SECOND GENERATION KNEE SYSTEM

K895145 is an FDA 510(k) clearance for SECOND GENERATION KNEE SYSTEM, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K895145 · Orthomet, Inc. · Orthopedic device
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Jul 1990
Decision
322d
Days
Class 2
Risk

K895145 is an FDA 510(k) clearance for the SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 6, 1990 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Orthomet, Inc. devices

FDA 510(k) Submission Details - K895145

510(k) Number K895145 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 18, 1989
Decision Date July 06, 1990
Days to Decision 322 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
200d slower than avg
Panel avg: 122d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K895145.
NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM)
K902335 · Intermedics Orthopedics · Aug 1990
AMK UNIVERSAL FEMORAL COMPONENT
K902246 · Depuy, Inc. · Aug 1990
ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED
K901406 · Depuy, Inc. · Jul 1990
PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
K901936 · Orthomet, Inc. · Jul 1990
WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM
K901992 · Dow Corning Wright · Jun 1990
CONTINUUM KNEE SYSTEM (CKS)
K901457 · Techmedica, Inc. · Jun 1990