Cleared Traditional

K870273 - LACEY METAL BACKED PATELLA PROSTHESIS

K870273 is an FDA 510(k) clearance for LACEY METAL BACKED PATELLA PROSTHESIS, manufactured by Dow Corning Wright. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K870273 · Dow Corning Wright · Orthopedic device
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Jul 1987
Decision
155d
Days
Class 2
Risk

K870273 is an FDA 510(k) clearance for the LACEY METAL BACKED PATELLA PROSTHESIS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on July 1, 1987 after a review of 155 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 Dow Corning Wright devices

FDA 510(k) Submission Details - K870273

510(k) Number K870273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1987
Decision Date July 01, 1987
Days to Decision 155 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
33d slower than avg
Panel avg: 122d · This submission: 155d
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 K870273.
WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY
K871776 · Dow Corning Wright · Aug 1987
GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)
K871146 · Richards Medical Co., Inc. · Jul 1987
MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM
K871585 · Depuy, Inc. · Jul 1987
KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY
K871772 · Howmedica Corp. · Jun 1987
OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION)
K871769 · Osteonics Corp. · Jun 1987
NOILES TOTAL KNEE PROSTHESIS
K870730 · Joint Medical Products Corp. · May 1987