Cleared Special

K000797 - OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01

K000797 is an FDA 510(k) clearance for OBL 2.0 MM MINI TAC ANCHOR, manufactured by Orthopaedic Biosystems, Ltd.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Special 510(k) pathway after a 21-day FDA review.

K000797 · Orthopaedic Biosystems, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
21d
Days
Class 2
Risk

K000797 is an FDA 510(k) clearance for the OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Orthopaedic Biosystems, Ltd. (Scottsdale, US). The FDA issued a Cleared decision on April 3, 2000 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Orthopaedic Biosystems, Ltd. devices

FDA 510(k) Submission Details - K000797

510(k) Number K000797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date April 03, 2000
Days to Decision 21 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

JDR Device Classification - Class 2, Special Controls

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 191
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K000797.
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · Medtronic Sofamor Danek, Inc. · Oct 2001
THE UNI-CLIP STAPLE
K011716 · New Deal, S.A. · Aug 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · Avanta Orthopaedics, Inc. · May 2001
MEMOGRAPH STAPLE, WARM SYSTEM
K993714 · Biomedical Ent., Inc. · Feb 2000
EIS DYNAMIC MEMORY STAPLES SYSTEM
K991962 · Groupe Lepine · Jan 2000
SOLUSTAPLE
K991566 · New Deal, S.A. · Aug 1999