Cleared Traditional

K990770 - BIORC ANCHOR

K990770 is an FDA 510(k) clearance for BIORC 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 143-day FDA review.

K990770 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
143d
Days
Class 2
Risk

K990770 is an FDA 510(k) clearance for the BIORC 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 July 30, 1999 after a review of 143 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 Linvatec Corp. devices

FDA 510(k) Submission Details - K990770

510(k) Number K990770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1999
Decision Date July 30, 1999
Days to Decision 143 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 122d · This submission: 143d
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 K990770.
BIOBUTTON
K990194 · Linvatec Corp. · Sep 1999
MODUS SYSTEM SELF-DRILLING SCREWS
K992106 · Medartis AG · Sep 1999
REUNITE SCREWS
K992301 · Biomet Manufacturing, Inc. · Sep 1999
STAPLETAC BONE ANCHOR SYSTEM
K992277 · Influence, Inc. · Jul 1999
SPIN SNAP-OFF SCREW
K991477 · New Deal, S.A. · Jul 1999
BIO-INTERFERENCE SCREW
K990454 · Innovasive Devices, Inc. · Jul 1999