Cleared Traditional

K924941 - CONCEPT 4MM CANCELLOUS SCREW WITH EYELET

K924941 is the FDA 510(k) clearance for CONCEPT 4MM CANCELLOUS SCREW WITH EYELET by Linvatec Corp.. It is a Class 2 Orthopedic device (product code JDR) cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K924941 · Linvatec Corp. · Orthopedic device
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Jun 1993
Decision
247d
Days
Class 2
Risk

K924941 is an FDA 510(k) clearance for the CONCEPT 4MM CANCELLOUS SCREW WITH EYELET. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on June 4, 1993 after a review of 247 days - an extended review 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: 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 Linvatec Corp. devices

Submission Details

510(k) Number K924941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1992
Decision Date June 04, 1993
Days to Decision 247 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 122d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, 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 - JDR Staple, Fixation, Bone

All 97
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K924941.
STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE
K926384 · Zimmer, Inc. · Nov 1993
ACUFEX SURETAC(R) PAC
K930538 · Acufex Microsurgical, Inc. · Sep 1993
ACUFEX(R) TAG(TM)
K911293 · Acufex Microsurgical, Inc. · Jul 1993
HARPOON SUTURE ANCHOR
K926037 · Biomet, Inc. · May 1993
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE
K911837 · Acufex Microsurgical, Inc. · Nov 1991
BONE STAPLE(S)
K904553 · Synthes (Usa) · Dec 1990