Cleared Traditional

K080685 - HIPLOC COMPRESSION HIP SCREW

K080685 is the FDA 510(k) clearance for HIPLOC COMPRESSION HIP SCREW by Biomet Manufacturing, Inc.. It is a Class 2 Orthopedic device (product code JDO) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K080685 · Biomet Manufacturing, Inc. · Orthopedic device
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Aug 2008
Decision
157d
Days
Class 2
Risk

K080685 is an FDA 510(k) clearance for the HIPLOC COMPRESSION HIP SCREW. Classified as Device, Fixation, Proximal Femoral, Implant (product code JDO), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 15, 2008 after a review of 157 days - an extended review 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: 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 Biomet Manufacturing, Inc. devices

Submission Details

510(k) Number K080685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2008
Decision Date August 15, 2008
Days to Decision 157 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 122d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K080685.
CONQUEST FN
K193029 · Smith & Nephew, Inc. · Feb 2020
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K173826 · Biomet, Inc. · Feb 2018
TSP HIP FRACTURE PLATING SYSTEM
K140018 · Biomet, Inc. · Apr 2014
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW
K080434 · Smith & Nephew, Inc. · Apr 2008
SYNTHES (USA) DHS HELIX SYSTEM
K981757 · Synthes (Usa) · Jul 1998
SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION
K964259 · Synthes (Usa) · Jan 1997