Cleared Traditional

K875050 - ORTHOMET BONE SCREWS

K875050 is an FDA 510(k) clearance for ORTHOMET BONE SCREWS, manufactured by Orthomet, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K875050 · Orthomet, Inc. · Orthopedic device
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Jan 1988
Decision
30d
Days
Class 2
Risk

K875050 is an FDA 510(k) clearance for the ORTHOMET BONE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 7, 1988 after a review of 30 days - a notably fast clearance 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: 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 Orthomet, Inc. devices

FDA 510(k) Submission Details - K875050

510(k) Number K875050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1987
Decision Date January 07, 1988
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 680
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K875050.
ACE CANCELLOUS BONE SCREW
K882831 · Buckman Co., Inc. · Aug 1988
INTERFERENCE SCREW
K874676 · Concept, Inc. · Mar 1988
ACROMED CANCELLOUS BONE SCREW
K875053 · Buckman Co., Inc. · Jan 1988
ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW
K874670 · Buckman Co., Inc. · Dec 1987
ACE CORTICAL LAG SCREW
K874672 · Buckman Co., Inc. · Dec 1987
TITANIUM BONE SCREWS
K874130 · Orthopedic Systems, Inc. · Dec 1987