Cleared Traditional

K810061 - CURVED SHERMAN BONE PLATE

K810061 is the FDA 510(k) clearance for CURVED SHERMAN BONE PLATE by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K810061 · Howmedica Corp. · Orthopedic device
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Jan 1981
Decision
10d
Days
Class 2
Risk

K810061 is an FDA 510(k) clearance for the CURVED SHERMAN 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. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1981 after a review of 10 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 Howmedica Corp. devices

Submission Details

510(k) Number K810061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date January 23, 1981
Days to Decision 10 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
112d faster than avg
Panel avg: 122d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K810061.
DYNAMIC CONDYLAR SCREW OR D.C.S.
K840954 · Synthes (Usa) · May 1984
ACE BROOKER BONE PLATING SYSTEM
K833865 · Buckman Co., Inc. · Dec 1983
CRYOPHTHALMIC UNIT
K811244 · Keeler Instruments, Inc. · Jun 1981
POLYETHYLENE FILLED BONE PLATE
K801603 · Zimmer, Inc. · Oct 1980
I.C.S. MINI & SMALL FRAGMENT SET
K800806 · Howmedica Corp. · Apr 1980
MULTIPLICITY OF PRODUCTS
K782123 · Depuy, Inc. · Jan 1979