Cleared Traditional

K923443 - NATURAL-KNEE ALL-POLY TIBIA

K923443 is an FDA 510(k) clearance for NATURAL-KNEE ALL-POLY TIBIA, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K923443 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
261d
Days
Class 2
Risk

K923443 is an FDA 510(k) clearance for the NATURAL-KNEE ALL-POLY TIBIA. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 261 days - an extended review cycle.

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. 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K923443

510(k) Number K923443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date March 31, 1993
Days to Decision 261 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 122d · This submission: 261d
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 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K923443.
APOLLO(TM) KNEE SYSTEM
K925242 · Intermedics Orthopedics · Jun 1993
ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT
K926257 · Dow Corning Wright · May 1993
WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP
K915525 · Dow Corning Wright · May 1993
KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER
K925901 · Howmedica Corp. · Mar 1993
DURACON METAL BACKED PATELLA
K923573 · Howmedica Corp. · Mar 1993
FEMORAL & TIBIAL AUGMENT BLOCK
K924940 · Joint Medical Products Corp. · Mar 1993