Cleared Traditional

K935448 - LUHR MINI BONE SCREW AND Z PLATE

K935448 is an FDA 510(k) clearance for LUHR MINI BONE SCREW AND Z 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 103-day FDA review.

K935448 · Howmedica Corp. · Orthopedic device
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Feb 1994
Decision
103d
Days
Class 2
Risk

K935448 is an FDA 510(k) clearance for the LUHR MINI BONE SCREW AND Z 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 February 23, 1994 after a review of 103 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 - K935448

510(k) Number K935448 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 12, 1993
Decision Date February 23, 1994
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 1226
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K935448.
STRAIGHT MINI-PLATE
K931691 · Onyx Medical Corp. · Apr 1994
1/3 TUBULAR PLATE
K931693 · Onyx Medical Corp. · Apr 1994
1/4 TUBULAR PLATE
K931694 · Onyx Medical Corp. · Apr 1994
ALPHATEC COMPRESSION AND RECONSTRUCTION PLATES
K933112 · Alphatec Mfg., Inc. · Feb 1994
BONE PLATE
K931244 · Acu Med, Inc. · Feb 1994
ACE UNIVERSAL RECONSTRUCTION PLATE
K930592 · Ace Medical Co. · Jul 1993