STABLELOC II EXTERNAL FIXATOR
Device Facts
| Record ID | K965029 |
|---|---|
| Device Name | STABLELOC II EXTERNAL FIXATOR |
| Applicant | Acu Med, Inc. |
| Product Code | JEC · Orthopedic |
| Decision Date | Feb 19, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3040 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Stableloc II External Fixation System consists of an external fixation device and a selection of threaded guide pins. The external fixator is not intended for implantation, only as a tool in surgery. It holds in place the pins which provide fracture reduction and alignment. The Stableloc II External Fixation System is used to address Colles' fractures and distal radial osteotomies and is not intended for use in the spine.
Device Story
Stableloc II External Fixation System; external fixation device with threaded guide pins. Used for fracture reduction and alignment of Colles' fractures and distal radial osteotomies. Device holds two proximal and two distal guide pins; allows pin adjustment. Used in surgical setting by clinicians. Fixator manufactured from Ultem, aluminum, stainless steel, titanium; guide pins from stainless steel. Fixator provided non-sterile (steam sterilization required); guide pins provided sterile (gamma radiation).
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Materials: Ultem, aluminum, stainless steel, titanium. Guide pins: stainless steel per ASTM F 138. Fixator: non-sterile, steam sterilized (SAL 10^-6). Guide pins: sterile, gamma radiation (min 2.5 megarads, AAMI Method 1, SAL 10^-6).
Indications for Use
Indicated for patients requiring fracture reduction and alignment for Colles' fractures and distal radial osteotomies. Not indicated for use in the spine.
Regulatory Classification
Identification
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Predicate Devices
- EBI Medical System's Orthofix Dynamic Axial Fixation System
Related Devices
- K013503 — MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR · DePuy Orthopaedics, Inc. · Nov 16, 2001
- K982982 — MINI-FIXATOR FOR COLLES FRACTURES · Biomet, Inc. · Oct 13, 1998
- K012294 — WRISTORE FIXATOR · Millennium Medical Technologies, Inc. · Mar 4, 2002
- K030198 — HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM · Hand Innovations, Inc. · Apr 1, 2003
- K191641 — AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws · Industrias Medicas Sampedro S.A.S · Sep 16, 2019
