Cleared Traditional

K851566 - HOWMEDICA FEMORAL COMPONENT HIP SYS 6259

K851566 is an FDA 510(k) clearance for HOWMEDICA FEMORAL COMPONENT HIP SYS 6259, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K851566 · Howmedica Corp. · Orthopedic device
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Jul 1985
Decision
105d
Days
Class 2
Risk

K851566 is an FDA 510(k) clearance for the HOWMEDICA FEMORAL COMPONENT HIP SYS 6259. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Howmedica Corp. devices

FDA 510(k) Submission Details - K851566

510(k) Number K851566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date July 30, 1985
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDG Device Classification - Class 2, Special Controls

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 47
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K851566.
THOMPSON HIP PROSTHESIS
K874617 · Orthopedic Systems, Inc. · Dec 1987
HOWMEDICA PCA COLLARED FEMORAL STEM
K873458 · Howmedica Corp. · Sep 1987
PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
K873089 · Howmedica Corp. · Sep 1987
BDH UNIVERSAL HIP SYSTEM SURGEON
K833468 · Carbomedics, Inc. · Dec 1983
BIOPHASE IMPLANT MATERIAL
K792329 · Richard'S Medical Equip., Inc. · Jan 1980
PROSTHESIS, HIP, CATHCART, SCHILLER MOD.
K780773 · Depuy, Inc. · Jun 1978