Cleared Traditional

CASF CANCELLOUS BONE SCREW, BT650 (K882934) - FDA 510(k) Clearance

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

K882934 · Terray Manufacturing, Inc. · Orthopedic device
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Oct 1988
Decision
92d
Days
Class 2
Risk

K882934 is an FDA 510(k) clearance for the CASF CANCELLOUS BONE SCREW, BT650. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Terray Manufacturing, Inc. (Ontario K7s 1l8, CA). The FDA issued a Cleared decision on October 13, 1988 after a review of 92 days - within the typical 510(k) review window.

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.

View all Terray Manufacturing, Inc. devices

Submission Details

510(k) Number K882934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1988
Decision Date October 13, 1988
Days to Decision 92 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 405
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K882934.
OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS
K894124 · Osteonics Corp. · Sep 1989
DEPUY CANNULATED BONE SCREW
K893512 · Depuy, Inc. · Aug 1989
VECSEI EXPANDING SCREW
K892925 · Howmedica Corp. · Aug 1989
OMNIFIT BONE SCREW
K873251 · Osteonics Corp. · Sep 1987
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM
K864633 · Howmedica Corp. · Dec 1986
BONE SCREW
K831873 · W.L. Gore & Associates, Inc. · Aug 1983