Cleared Traditional

A.L.P.S. Small Fragment Plating System (K243761) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243761 · Biomet Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
75d
Days
Class 2
Risk

K243761 is an FDA 510(k) clearance for the A.L.P.S. Small Fragment Plating System. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Biomet Orthopedics (Warsaw, US). The FDA issued a Cleared decision on February 19, 2025 after a review of 75 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 Biomet Orthopedics devices

Submission Details

510(k) Number K243761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2024
Decision Date February 19, 2025
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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 697
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K243761.
APTUS Hand System
K243610 · Medartis AG · Mar 2025
CastleLoc Pectus Bar System
K243357 · L & K Biomed Co., Ltd. · Feb 2025
EVOS Pelvic and Acetabular System
K241666 · Smith & Nephew · Feb 2025
Locking Plates and Screws Systems
K240958 · Hebei Ruihe Medical Devices Co., Ltd. · Feb 2025
Signature Osteosynthesis Plate System
K241599 · Signature Orthopaedic Pty , Ltd. · Feb 2025
BPS - Bone Fragment Fixation Plates, Screws and Washers
K250055 · Orthonovis, Inc. · Feb 2025