Cleared Traditional

K810258 - PROXIMAL FERMORAL HIP REPLACEMENT

K810258 is an FDA 510(k) clearance for PROXIMAL FERMORAL HIP REPLACEMENT, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDO cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K810258 · Biomet, Inc. · Orthopedic device
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Mar 1981
Decision
34d
Days
Class 2
Risk

K810258 is an FDA 510(k) clearance for the PROXIMAL FERMORAL HIP REPLACEMENT. Classified as Device, Fixation, Proximal Femoral, Implant (product code JDO), Class II - Special Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1981 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K810258

510(k) Number K810258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1981
Decision Date March 05, 1981
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDO Device Classification - Class 2, Special Controls

Product Code JDO Device, Fixation, Proximal Femoral, Implant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDO Device, Fixation, Proximal Femoral, Implant

All 18
Devices cleared under the same product code (JDO) and FDA review panel - the closest regulatory comparables to K810258.
PROFORM HA HIP SYSTEM
K934162 · Stelkast Company · Mar 1994
SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
K923613 · Synthes (Usa) · Jun 1993
COMPRESSION SYSTEM
K831076 · Kirschner Medical Corp. · Apr 1983
BIOMET CONCENTRIC HEX SCREW
K781389 · Biomet, Inc. · Aug 1978
NAIL, MASSIE II
K780187 · Howmedica Corp. · Mar 1978