Cleared Traditional

K922525 - DALL MILES BROAD BONE PLATE

K922525 is an FDA 510(k) clearance for DALL MILES BROAD BONE PLATE, manufactured by Howmedica Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K922525 · Howmedica Corp. · Orthopedic device
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Sep 1992
Decision
117d
Days
Class 2
Risk

K922525 is an FDA 510(k) clearance for the DALL MILES BROAD BONE PLATE. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 22, 1992 after a review of 117 days - within the typical 510(k) review window.

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 Howmedica Corp. devices

FDA 510(k) Submission Details - K922525

510(k) Number K922525 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 28, 1992
Decision Date September 22, 1992
Days to Decision 117 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
5d faster than avg
Panel avg: 122d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 1222
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K922525.
LUHR PAN FIXATION SYSTEM
K923861 · Howmedica Corp. · Mar 1993
ANSPACH MINI-PLATING SYSTEM
K921338 · The Anspach Effort, Inc. · Feb 1993
RECONSTRUCTION PLATE SYSTEM
K924085 · Sofamor Danek Mfg., Inc. · Dec 1992
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K922167 · Alphatec Mfg., Inc. · Aug 1992
TMP MICROPLATING SYSTEM
K921458 · Techmedica, Inc. · Jul 1992
ALPHATEC COMPRESSION HIP SCREW SYSTEM
K921622 · Alphatec Mfg., Inc. · Jul 1992