Cleared Traditional

K914804 - RADIUS OSTEOTOMY PLATES

K914804 is an FDA 510(k) clearance for RADIUS OSTEOTOMY PLATES, manufactured by Link America, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K914804 · Link America, Inc. · Orthopedic device
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Apr 1992
Decision
188d
Days
Class 2
Risk

K914804 is an FDA 510(k) clearance for the RADIUS OSTEOTOMY PLATES. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Link America, Inc. (East Hanavor, US). The FDA issued a Cleared decision on April 29, 1992 after a review of 188 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 Link America, Inc. devices

FDA 510(k) Submission Details - K914804

510(k) Number K914804 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 24, 1991
Decision Date April 29, 1992
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
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 1042
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K914804.
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
SCHWABE RADIUS PLATES
K914803 · Link America, Inc. · Apr 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818 · Synthes (Usa) · Jan 1992
LUHR PAN FIXATION SYSTEM
K913355 · Howmedica Corp. · Dec 1991