Cleared Traditional

K991024 - BONE BULLET SUTURE ANCHOR

K991024 is an FDA 510(k) clearance for BONE BULLET SUTURE ANCHOR, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K991024 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
232d
Days
Class 2
Risk

K991024 is an FDA 510(k) clearance for the BONE BULLET SUTURE ANCHOR. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on November 16, 1999 after a review of 232 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.

View all Linvatec Corp. devices

FDA 510(k) Submission Details - K991024

510(k) Number K991024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date November 16, 1999
Days to Decision 232 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
110d slower than avg
Panel avg: 122d · This submission: 232d
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 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K991024.
EIS THREADED SCREW FRACTURE FIXATION
K991964 · Groupe Lepine · Dec 1999
ABSOLUTE ABSORBABLE INTERFERENCE SCREW
K993975 · Innovasive Devices, Inc. · Dec 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · Smith & Nephew, Inc. · Nov 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · Biomet, Inc. · Oct 1999
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
K992367 · Electro-Biology, Inc. · Sep 1999
MITEK ROTATOR CUFF QUICKANCHOR PLUS
K992611 · Mitek Products · Sep 1999