Cleared Traditional

K090175 - UNITY BETA PLLA SYSTEM

K090175 is an FDA 510(k) clearance for UNITY BETA PLLA SYSTEM, manufactured by Bonutti Research, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K090175 · Bonutti Research, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
230d
Days
Class 2
Risk

K090175 is an FDA 510(k) clearance for the UNITY BETA PLLA SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bonutti Research, Inc. (Effingham, US). The FDA issued a Cleared decision on September 10, 2009 after a review of 230 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

FDA 510(k) Submission Details - K090175

510(k) Number K090175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2009
Decision Date September 10, 2009
Days to Decision 230 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
108d slower than avg
Panel avg: 122d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 1053
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K090175.
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MERETE COMPRESSION SCREWS
K091798 · Merete Medical GmbH · Sep 2009
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K090949 · Synthes (Usa) · Jul 2009
EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
K091577 · Extremity Medical, LLC · Jul 2009
K090175 · UNITY BETA PLLA SYSTEM
Download PDF FDA Summary Bonutti Research, Inc.