Cleared Traditional

K070955 - ACID ETCHED LAG SCREWS

K070955 is an FDA 510(k) clearance for ACID ETCHED LAG SCREWS, manufactured by Biomet Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K070955 · Biomet Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Oct 2007
Decision
190d
Days
Class 2
Risk

K070955 is an FDA 510(k) clearance for the ACID ETCHED LAG SCREWS. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 12, 2007 after a review of 190 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Biomet Orthopedics, Inc. devices

FDA 510(k) Submission Details - K070955

510(k) Number K070955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2007
Decision Date October 12, 2007
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 470
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K070955.
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
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SANATMETAL NAILS AND PINS
K070761 · Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. · Feb 2008
METAFIX AND FIXION FA INTRAMEDULLARY NAILING SYSTEMS
K071679 · Disc-O-Tech Medical Technologies, Ltd. · Dec 2007
BIOMET FEMORAL LOCKING NAIL SYSTEM
K072161 · Biomet Manufacturing Corp · Sep 2007
ACUMED SMALL BONE LOCKING SYSTEM II
K071944 · Acumed, LLC · Aug 2007
AOS TIBIAL NAIL
K070444 · Advanced Orthopaedic Solutions, Inc. · Jun 2007