(315 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation aand 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.
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.
The provided document (K012634) is a 510(k) Pre-Market Notification for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This type of submission is for "reprocessed" medical devices, meaning devices that were originally intended for single use but are being re-used after cleaning, sterilization, and sometimes repair. The testing described focuses on demonstrating that the reprocessed devices perform as intended, similar to their original, new counterparts, and that the reprocessing method is effective.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance (Safety and Effectiveness) | Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness). |
| Biocompatibility | Validation of reprocessing included biocompatibility testing. |
| Validation of Reprocessing | Validation of reprocessing (methods for cleaning, sterilization, etc.) was performed. |
| Original Intended Performance Maintained | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
Note: The document states that the reprocessed devices are identical in design, materials, and intended use as the predicate devices, implying that the acceptance criteria are met if these characteristics and the performance benchmarks are maintained after reprocessing. The specific quantitative acceptance criteria values (e.g., specific tensile strength, fatigue life, or sterilization sterility assurance levels) are not detailed in this summary, but are generally part of the underlying bench and laboratory testing reports.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not explicitly state the sample size used for the test set in the performance, biocompatibility, or reprocessing validation studies. It only mentions "Bench and laboratory testing."
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for reprocessed devices, the data would typically be derived from controlled laboratory studies and possibly prior clinical use data of the original devices or reprocessed devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of submission for reprocessed devices typically relies on engineering and scientific experts to establish test protocols, analyze performance, and validate reprocessing methods, rather than clinical experts establishing a "ground truth" for a diagnostic or AI device. The document does not specify the number or qualifications of such experts involved in establishing the testing parameters or reviewing the results.
4. Adjudication Method for the Test Set
The concept of "adjudication method" (like 2+1, 3+1) is not applicable to this type of device submission. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement needs to be resolved to establish ground truth. For reprocessed external fixation devices, performance is assessed through objective physical, mechanical, and chemical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. External fixation devices are physical medical instruments, and their effectiveness is not assessed through human reader interpretation of cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This concept applies to AI/ML algorithms that operate independently. The device here is a physical external fixation device.
7. The Type of Ground Truth Used
For this device, the "ground truth" is established by objective engineering specifications, material properties, and sterility standards for external fixation devices. For instance:
- Mechanical Integrity: The reprocessed devices must meet the same mechanical strength, fatigue, and other performance characteristics as new, predicate devices.
- Biocompatibility: The materials must remain biocompatible after reprocessing.
- Sterility: The reprocessing must render the devices sterile, typically validated to a Sterility Assurance Level (SAL) of 10^-6.
- Cleaning Effectiveness: The devices must be effectively cleaned to remove biological and other foreign material.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning for AI algorithms. This submission is for reprocessed physical medical devices, not an AI/ML product.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" is not applicable to this device.
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510(k) Summary of Safety and Effectiveness
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 |
|---|---|
| Contact: | Don SelveyVice 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/MultipleComponent and Invasive Traction Component |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances andAccessories |
Reprocessed device(s):
ﻤﺴﺎﺑﻪ
| MANUFACTURER | MODELNUMBER | DESCRIPTION |
|---|---|---|
| SMITH & NEPHEW RICHARDS, INC. | 100100 | ILIZAROV TELESCOPIC ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100101 | ILIZAROV TELESCOPIC ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100102 | ILIZAROV TELESCOPIC ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100103 | ILIZAROV TELESCOPIC ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100105 | ILIZAROV GRAD. TELESCOPIC ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100106 | ILIZAROV GRAD. TELESCOPIC ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100107 | ILIZAROV GRAD. TELESCOPIC ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100108 | ILIZAROV GRAD. TELESCOPIC ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100110 | ILIZAROV PART. THREADED ROD |
| SMITH & NEPHEW RICHARDS, INC. | 100600 | ILIZAROV WIRE FIXATION BOLT SLOTTED |
| SMITH & NEPHEW RICHARDS, INC. | 100700 | ILIZAROV WIRE FIXATION BOLT SLOTTED |
| SMITH & NEPHEW RICHARDS, INC. | 100900 | ILIZAROV THREADED SOCKET |
| SMITH & NEPHEW RICHARDS, INC. | 100901 | ILIZAROV SOCKET, THREADED |
| SMITH & NEPHEW RICHARDS, INC. | 101302 | ILIZAROV HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 101307 | ILIZAROV HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 101309 | ILIZAROV HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 101351 | ILIZAROV COMPOSITE HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 101352 | ILIZAROV COMPOSITE HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 101355 | ILIZAROV COMPOSITE HALF RING |
| SMITH & NEPHEW RICHARDS, INC | 10-1357 | ILIZAROV COMPOSITE HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 10-1358 | ILIZAROV COMPOSITE HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 10-1359 | ILIZAROV COMPOSITE HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 101402 | ILIZAROV SUPPORT MASCULINE END |
| SMITH & NEPHEW RICHARDS, INC. | 101600 | ILIZAROV EXTERNAL FIXATION HINGE |
| SMITH & NEPHEW RICHARDS, INC. | 101602 | ILIZAROV LOW PROFILE MALE HINGE |
| SMITH & NEPHEW RICHARDS, INC. | 101800 | ILIZAROV SHORT CONNECTION PLATE 3-HOLE |
| SMITH & NEPHEW RICHARDS, INC. | 101810 | ILIZAROV STRAIGHT BAR 2-HOLE |
| SMITH & NEPHEW RICHARDS, INC. | 101900 | ILIZAROV TWISTED BAR 2-HOLE |
| SMITH & NEPHEW RICHARDS, INC. | 102300 | ILIZAROV ROD, THREADED |
| SMITH & NEPHEW RICHARDS, INC. | 103405 | ILIZAROV CENTERING SLEEVE |
| SMITH & NEPHEW RICHARDS, INC. | 103406 | ILIZAROV SQUARE WASHER |
| SMITH & NEPHEW RICHARDS, INC. | 10-345 | ILIZAROV EXTERNAL FIXATION DEVICE |
| SMITH & NEPHEW RICHARDS, INC. | 103451 | ILIZAROV CUBE (1-HOLE) |
| SMITH & NEPHEW RICHARDS, INC. | 201004 | ILIZAROV ARCH |
| SMITH & NEPHEW RICHARDS, INC. | 201300 | ILIZAROV OBLIQUE SUPPORT CONNECTION |
| SMITH & NEPHEW RICHARDS, INC. | 7110-1362 | ILIZAROV COMPOSITE RING |
| SMITH & NEPHEW RICHARDS, INC. | 71033002 | EXTERNAL TIBIAL FIXATOR |
| SMITH & NEPHEW RICHARDS, INC. | 71033006 | EXTERNAL TIBIAL FIXATOR |
| SMITH & NEPHEW RICHARDS, INC. | 10-0550 | CONNECTION BOLT |
| SMITH & NEPHEW RICHARDS, INC. | 10-0601 | WIRE FIXATION BOLT |
| SMITH & NEPHEW RICHARDS, INC. | 10-0800 | BUSHING |
| SMITH & NEPHEW RICHARDS, INC. | 10-1303 | HALF METAL RING |
| SMITH & NEPHEW RICHARDS, INC. | 10-1304 | METAL HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 10-1306 | HALF METAL RING |
| SMITH & NEPHEW RICHARDS, INC. | 10-1353 | COMPOSITE HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 10-1356 | COMPOSITE HALF RING |
| SMITH & NEPHEW RICHARDS, INC. | 10-1500 | POST FEMALE END 2 HOLES |
| SMITH & NEPHEW RICHARDS, INC. | 10-1700 | HINGE FEMALE END |
| SMITH & NEPHEW RICHARDS, INC. | 10-1702 | HINGE FEMALE END |
| SMITH & NEPHEW RICHARDS, INC. | 10-1901 | TWIST PLATE 3 HOLE |
| SMITH & NEPHEW RICHARDS, INC. | 10-2300 | THREADED ROD |
| SMITH & NEPHEW RICHARDS, INC. | 10-2301 | THREADED ROD |
| SMITH & NEPHEW RICHARDS, INC. | 10-2303 | THREADED ROD |
| SMITH & NEPHEW RICHARDS, INC. | 10-2304 | THREADED ROD |
| SMITH & NEPHEW RICHARDS, INC. | 10-2501 | HINGE 90 DEG. |
| SMITH & NEPHEW RICHARDS, INC. | 10-2706 | FIXATION BOLT WASHER |
| SMITH & NEPHEW RICHARDS, INC. | 10-2721 | SLOTTED WASHER |
| SMITH & NEPHEW RICHARDS, INC. | 10-3195 | CONNECTION BOLT |
| SMITH & NEPHEW RICHARDS, INC. | 10-3202 | CONNECTION BOLT |
| SMITH & NEPHEW RICHARDS, INC. | 10-3203 | CONNECTION BOLT |
| SMITH & NEPHEW RICHARDS, INC. | 10-3302 | 4PT. D/COUNTER |
| SMITH & NEPHEW RICHARDS, INC. | 10-3310 | HEX NUT |
| SMITH & NEPHEW RICHARDS, INC. | 10-3451 | CUBE 1 HOLE |
| SMITH & NEPHEW RICHARDS, INC. | 10-3453 | CUBE 3 HOLE |
| SMITH & NEPHEW RICHARDS, INC. | 20-1700 | CONICAL WASHER COUPLE |
| SMITH & NEPHEW RICHARDS, INC. | 7101-2005 | NYLON INSERT NUT |
| Predicate device(s): | K870961 | Smith & Nephew Richards, Inc., External FixationSystem |
| K962808 | Smith & Nephew Richards, Ilizarov ExternalFixation System | |
| K970713 | Smith & Nephew Richards Compass® ProximalInterphalangeal (PIP) Hinge | |
| Device description: | External fixation devices are specially designed frames, clamps, rods,rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixationbolts, washers, nuts, hinges, sockets, connecting bars and screws usedfor the management of bone fractures and reconstructive, as well ascorrective, orthopedic surgery. Materials used include metal alloys,plastic and composites. These materials are chosen to address a widerange of fractures and applications as well as to allow for theappropriate amount of rigidity and stability. | |
| Intended use: | External Fixation Devices are intended to be used for the fixation ofsupracondylar, or condylar fractures of the femur; for fusion of a joint;for surgical procedures that involve cutting the bone, for fixation ofbone fractures; bone reconstruction; as a guide pin for insertion of otherimplants; or may be implanted through the skin so that a pulling force ortraction may be applied to the skeletal system; and others may be usedfor fixation of bone fractures, for bone reconstructions, as a guide pinfor insertion of other implants, or it may be implanted through the skinso that a pulling force (traction) may be applied to the skeletal system. | |
| Indications statement: | Reprocessed external fixation devices are indicated for use in patientsrequiring external skeletal fixation oand treatment of fractures,osteotomy, arthrodesis, correction of deformities, fracture revision,bone reconstruction procedures, limb lengthening, correction of bonyor soft tissue deformities and segmental bony or soft tissue defects. | |
| Technological characteristics: | The design, materials, and intended use of the Reprocessed ExternalFixation Device s are identical to the predicate devices. Themechanism of action of the Reprocessed External Fixation Device isidentical to the predicate devices in that the same standardmechanical design, materials, shapes and sizes are utilized. There areno changes to the claims, intended use, clinical applications, patientpopulation, performance specifications, or method of operation. | |
| Performance data: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of the Reprocessed ExternalFixation Devices. | |
| BiocompatibilityValidation of reprocessing |
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KO12634
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34
Sopy
ﭘﺮ
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
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40Fy
Conclusion:
In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird with three lines representing its wings or feathers.
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.
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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 vour 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
Enclósure
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Indications for Use Statement
510(k) Number (if known):
510(k) Number (if known):
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 aand 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 | MODELNUMBER | DESCRIPTION | |
|---|---|---|---|
| SMITH & NEPHEW RICHARDS, INC. | 100100 | ILIZAROV TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100101 | ILIZAROV TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100102 | ILIZAROV TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100103 | ILIZAROV TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100105 | ILIZAROV GRAD. TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100106 | ILIZAROV GRAD. TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100107 | ILIZAROV GRAD. TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100108 | ILIZAROV GRAD. TELESCOPIC ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100110 | ILIZAROV PART. THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 100600 | ILIZAROV WIRE FIXATION BOLT SLOTTED | |
| SMITH & NEPHEW RICHARDS, INC. | 100700 | ILIZAROV WIRE FIXATION BOLT SLOTTED | |
| SMITH & NEPHEW RICHARDS, INC. | 100900 | ILIZAROV THREADED SOCKET | |
| SMITH & NEPHEW RICHARDS, INC. | 100901 | ILIZAROV SOCKET, THREADED | |
| SMITH & NEPHEW RICHARDS, INC. | 101302 | ILIZAROV HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101307 | ILIZAROV HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101309 | ILIZAROV HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101351 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101352 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101355 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1357 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1358 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1359 | ILIZAROV COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 101402 | ILIZAROV SUPPORT MASCULINE END | |
| SMITH & NEPHEW RICHARDS, INC. | 101600 | ILIZAROV EXTERNAL FIXATION HINGE | |
| SMITH & NEPHEW RICHARDS, INC. | 101602 | ILIZAROV LOW PROFILE MALE HINGE | |
| 510(k) Number | SMITH & NEPHEW RICHARDS, INC. | 101800 | ILIZAROV SHORT CONNECTION PLATE 3-HOLE |
| SMITH & NEPHEW RICHARDS, INC. | 101810 | ILIZAROV STRAIGHT BAR 2-HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 101900 | ILIZAROV TWISTED BAR 2-HOLE | |
| K012634 | SMITH & NEPHEW RICHARDS, INC. | 102300 | ILIZAROV ROD, THREADED |
| SMITH & NEPHEW RICHARDS, INC. | 103405 | ILIZAROV CENTERING SLEEVE | |
| SMITH & NEPHEW RICHARDS, INC. | 103406 | ILIZAROV SQUARE WASHER | |
| SMITH & NEPHEW RICHARDS, INC. | 10-345 | ILIZAROV EXTERNAL FIXATION DEVICE | |
| SMITH & NEPHEW RICHARDS, INC. | 103451 | ILIZAROV CUBE (1-HOLE) | |
| SMITH & NEPHEW RICHARDS, INC. | 201004 | ILIZAROV ARCH | |
| SMITH & NEPHEW RICHARDS, INC. | 201300 | ILIZAROV OBLIQUE SUPPORT CONNECTION | |
| SMITH & NEPHEW RICHARDS, INC. | 7110-1362 | ILIZAROV COMPOSITE RING | |
| SMITH & NEPHEW RICHARDS, INC. | 71033002 | EXTERNAL TIBIAL FIXATOR | |
| SMITH & NEPHEW RICHARDS, INC. | 71033006 | EXTERNAL TIBIAL FIXATOR | |
| SMITH & NEPHEW RICHARDS, INC. | 10-0550 | CONNECTION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-0601 | WIRE FIXATION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-0800 | BUSHING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1303 | HALF METAL RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1304 | METAL HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1306 | HALF METAL RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1353 | COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1356 | COMPOSITE HALF RING | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1500 | POST FEMALE END 2 HOLES | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1700 | HINGE FEMALE END | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1702 | HINGE FEMALE END | |
| SMITH & NEPHEW RICHARDS, INC. | 10-1901 | TWIST PLATE 3 HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2300 | THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2301 | THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2303 | THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2304 | THREADED ROD | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2501 | HINGE 90 DEG. | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2706 | FIXATION BOLT WASHER | |
| SMITH & NEPHEW RICHARDS, INC. | 10-2721 | SLOTTED WASHER | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3195 | CONNECTION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3202 | CONNECTION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3203 | CONNECTION BOLT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3302 | 4PT. D/COUNTER | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3310 | HEX NUT | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3451 | CUBE 1 HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3452 | CUBE 2 HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 10-3453 | CUBE 3 HOLE | |
| SMITH & NEPHEW RICHARDS, INC. | 20-1700 | CONICAL WASHER COUPLE | |
| SMITH & NEPHEW RICHARDS, INC. | 7101-2005 | NYLON INSERT NUT |
CONFIDENTIAL
sion Sign-Off)
ion of General, Restor
Icurological Devices
Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
CONFIDENTIAL
2 Miller
Sion Sign-Off)
Lion of General, Restoration Restoration of General, Restoration of Genrological Devices
Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.