(315 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and reprocessing of external fixation devices, with no mention of AI or ML.
Yes
The device description and intended use clearly state that it is used for the treatment and management of fractures, osteotomy, arthrodesis, correction of deformities, and other bone reconstruction procedures, which are therapeutic applications.
No
The device description and intended use clearly state that external fixation devices are used for treatment of fractures, osteotomy, and other orthopedic procedures, not for diagnostic purposes.
No
The device description explicitly lists various hardware components (frames, clamps, rods, pins, etc.) made of metal alloys, plastic, and composites, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as an external skeletal fixation system for treating fractures, deformities, and other orthopedic conditions. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the physical components of the external fixation device (frames, clamps, rods, etc.) and the materials used. This aligns with a surgical implant/device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.), detect biomarkers, or provide information for diagnosis.
- Performance Studies: The performance studies focus on biocompatibility and validation of reprocessing, which are relevant to the safety and effectiveness of a surgical device, not the analytical or clinical performance of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Product codes
KTT, KTW, JEC
Device Description
External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices.
- Biocompatibility
- Validation of reprocessing
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
Key Metrics
Not Found
Predicate Device(s)
K000682, K010344, K914558, K961350, K962484, K973017, K963618
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K012623
10F3
510(k) Summary of Safety and Effectiveness
Submitter:
Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Contact:
Don Selvey Vice President, Regulatory Affairs and Quality Assurance (480) 763-5300
| Date of preparation: | 8 August 2001 |
|---|---|
| Name of device: | Reprocessed External Fixation Devices |
| Common Name: | External Fixation Devices, Fixation Appliance, Single/Multiple |
| Component and Invasive Traction Component | |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances and |
| Accessories |
Reprocessed device(s):
| MANUFACTURER | MODEL NUMBER | DESCRIPTION |
|---|---|---|
| SYNTHES (USA) | 392.88 | NUT FOR 8.0MM THREADED RODS |
| SYNTHES (USA) | 393.36 | TUBE-TO-TUBE CLAMP |
| SYNTHES (USA) | 393.361 | TITANIUM ROD-TO-ROD CLAMP |
| SYNTHES (USA) | 393.436 | RING-TO-ROD CLAMP |
| SYNTHES (USA) | 393.44 | EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.45 | EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.464 | ADJUSTABLE PIN CLAMP |
| SYNTHES (USA) | 393.48 | ANGLED EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.64 | ROD-TO-PIN ADJUSTABLE CLAMP |
| SYNTHES (USA) | 393.647 | COMBINATION CLAMP |
| SYNTHES (USA) | 393.71 | UNIVERSAL JOINT FOR TWO TUBES |
| SYNTHES (USA) | 393.722 | 3/4 FIXATION RING |
| SYNTHES (USA) | 393.732 | 3/4 STEEL RING |
| SYNTHES (USA) | 393.734 | 3/4 EXTERNAL FIXATION RING |
| SYNTHES (USA) | 393.736 | 3/4 EXTERNAL FIXATION RING |
| SYNTHES (USA) | 393.751 | ROD-TO-PIN UNIVERSAL CLAMP |
| SYNTHES (USA) | 393.753 | ROD CLAMP |
| SYNTHES (USA) | 393.756 | ROD TO ROD CLAMP |
| SYNTHES (USA) | 394.8 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.80 | CARBON FIBER ROD |
1
| MANUFACTURER | MODEL NUMBER | DESCRIPTION |
|---|---|---|
| SYNTHES (USA) | 394.82 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.83 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.84 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.85 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.86 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.87 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.55 | OPEN CLAMP |
| SYNTHES (USA) | 395.56 | PIN TO ROD COUPLER |
| SYNTHES (USA) | 395.57 | ROD TO ROD COUPLER |
| SYNTHES (USA) | 395.597 | ROD TO PIN COUPLER |
| SYNTHES (USA) | 395.6 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.62 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.63 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.64 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.65 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.66 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.72 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.73 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.73C | CONTRA ROD |
| SYNTHES (USA) | 395.74 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.75 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.76 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.77 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.782 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.784 | CARBON FIBER ROD |
| SYNTHES (USA) | 459.014 | EXTERNAL FIXATION DEVICE |
| SYNTHES (USA) | 633-200 | STEEL ROD |
| SYNTHES (USA) | B18-200 | STEEL ROD |
| SYNTHES (USA) | B18-300 | STEEL ROD |
| SYNTHES (USA) | B18-350 | STEEL ROD |
| SYNTHES (USA) | B18-400 | STEEL ROD |
20F3
Predicate device(s): Synthes Large Fragment DCL System K000682 K010344 Synthes (USA) Adjustable Large Fixator System Synthes TraumaFix™ External Fixator K914558 Synthes (U.S.A.) Mini External Fixator K961350 K962484 Synthes Titanium External Fixator Clamps Synthes K973017 Combination Clamp and Dynamization Clip K963618 Synthes Simple Small External Fixator Device description: External fixation devices are specially designed frames, clamps, rods,
rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used
2
2623 30F 3
for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
External Fixation Devices are intended to be used for the fixation of Intended use: supracondylar, or condylar fractures of the femur: for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants: or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system.
Reprocessed external fixation devices are indicated for use in patients Indications statement: requiring external skeletal fixation oand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
The design, materials, and intended use of the Reprocessed External Technological characteristics: Fixation Device s are identical to the predicate devices. The mechanism of action of the Reprocessed External Fixation Device is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed External Fixation Device s.
- Biocompatibility ●
- Validation of reprocessing
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Conclusion: Part 807 and based on the information provided in this premarket notification, Alliance Medical Corporation concludes that the modified device (the Reprocessed External Fixation Device) is safe, effective and substantially equivalent to the predicate devices as described herein.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The image within the circle appears to be an abstract representation of a human figure or a bird-like shape. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2002
Mr. Don Selvey Vice President Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: (K012623) K012634, K012645, K012648
Trade Name: Reprocessed External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, KTW, JEC Dated: April 3, 2002 Received: April 4, 2002
Dear Mr. Selvey:
We have reviewed your Section 510(k) premarket notifications of intent to market the devices referenced above and have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Don Selvey
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices : to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
sincerely yours,
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
(012623
Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices
Indications for Use: Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
| MANUFACTURER | MODEL
NUMBER | DESCRIPTION |
|---------------|-----------------|--------------------------------|
| SYNTHES (USA) | 392.88 | NUT FOR 8.0MM THREADED RODS |
| SYNTHES (USA) | 393.36 | TUBE-TO-TUBE CLAMP |
| SYNTHES (USA) | 393.361 | TITANIUM ROD-TO-ROD CLAMP |
| SYNTHES (USA) | 393.436 | RING-TO-ROD CLAMP |
| SYNTHES (USA) | 393.44 | EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.45 | EXTERNIAL FIXATION CLAMP |
| SYNTHES (USA) | 393.464 | ADJUSTABLE PIN CLAMP |
| SYNTHES (USA) | 393.48 | ANGLED EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.64 | ROD-TO-PIN ADJUSTABLE CLAMP |
| SYNTHES (USA) | 393.647 | COMBINATION CLAMP |
| SYNTHES (USA) | 393.71 | UNIVERSAL JOINT FOR TWO TUBES |
| SYNTHES (USA) | 393.722 | 3/4 FIXATION RING |
| SYNTHES (USA) | 393.732 | 3/4 STEEL RING |
| SYNTHES (USA) | 393.734 | 3/4 EXTERNAL FIXATION RING |
| SYNTHES (USA) | 393.736 | 3/4 EXTERNAL FIXATION RING |
| SYNTHES (USA) | 393.751 | ROD-TO-PIN UNIVERSAL CLAMP |
| SYNTHES (USA) | 393.753 | ROD CLAMP |
| SYNTHES (USA) | 393.756 | ROD TO ROD CLAMP |
| SYNTHES (USA) | 394.8 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.80 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.82 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.83 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.84 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.85 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.86 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.87 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.55 | OPEN CLAMP |
CONFIDENTIAL
Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)
6
| SYNTHES (USA) | 395.56 | PIN TO ROD COUPLER |
|---|---|---|
| SYNTHES (USA) | 395.57 | ROD TO ROD COUPLER |
| SYNTHES (USA) | 395.597 | ROD TO PIN COUPLER |
| SYNTHES (USA) | 395.6 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.62 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.63 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.64 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.65 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.66 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.72 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.73 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.73C | CONTRA ROD |
| SYNTHES (USA) | 395.74 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.75 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.76 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.77 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.782 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.784 | CARBON FIBER ROD |
| SYNTHES (USA) | 459.014 | EXTERNAL FIXATION DEVICE |
| SYNTHES (USA) | 633-200 | STEEL ROD |
| SYNTHES (USA) | B18-200 | STEEL ROD |
| SYNTHES (USA) | B18-300 | STEEL ROD |
| SYNTHES (USA) | B18-350 | STEEL ROD |
| SYNTHES (USA) | B18-400 | STEEL ROD |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Mark n Milk (Division Sign-Off) Division of General, Restorative | ||
| and Neurological Devices | ||
| 510(k) Number | K012623 | |
| Prescription Use | ||
| (per 21 CFR 801.109) | or | Over-the-Counter Use |
(per 21 CFR 801.109)
CONFIDENTIAL