(83 days)
Fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft.
Synthes Hybrid External Fixator Modifications are components of the Synthes Hybrid External Fixator, a ring and wire based external fixator that forms a construct intended for the stabilization of complex proximal and/or distal tibial fractures. It is designed for use with the Synthes Large Exernal Fixator and may be used in conjunction with other fixation methods. The proposed components consist of an Adjustable Wire/Pin Clamp, a Low-Profile Adjustable Wire/Pin Clamp and Ring-To-Rod Clamp.
The provided text is a 510(k) summary for the Synthes (USA) Hybrid External Fixator Modifications device. It describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the document does NOT contain information regarding:
- Acceptance criteria and reported device performance (Table 1)
- Study details (sample size, data provenance, expert numbers/qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth establishment).
The 510(k) summary focuses on demonstrating substantial equivalence based on the device's design, materials, and intended use being similar to a previously cleared device (Synthes Hybrid External Fixator, K950384). It is a regulatory submission, not a study report detailing performance metrics against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text. This type of information is typically found in design validation reports, clinical study reports, or detailed performance testing summaries, which are not part of this 510(k) public abstract.
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and the comments of the comments of the comments of the comments of
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4073135 (pg 11)
| 3.0 | 510(k) Summary | Page 1 of 1 |
|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380P (610) 719-6538F (484) 356-9682 | |
| Device Name: | Synthes (USA) Hybrid External Fixator Modifications | |
| Classification: | 21 CFR Part 888.3030 - Single/multiple component bone fixationappliances and accessories, Class II. | |
| Predicate Device: | Synthes (USA) Hybrid External Fixator (K950384) | |
| Device Description: | Synthes Hybrid External Fixator Modifications are components ofthe Synthes Hybrid External Fixator, a ring and wire based externalfixator that forms a construct intended for the stabilization ofcomplex proximal and/or distal tibial fractures. It is designed foruse with the Synthes Large Exernal Fixator and may be used inconjunction with other fixation methods. The proposedcomponents consist of an Adjustable Wire/Pin Clamp, a Low-Profile Adjustable Wire/Pin Clamp and Ring-To-Rod Clamp. | |
| Intended Use: | Synthes Hybrid External Fixator Modifications are part of theSynthes Hybrid External Fixator system which is indicated for:fixation of proximal and/or distal tibial fractures, with orwithout extension into the tibial shaft. | |
| SubstantialEquivalence: | Documentation is provided which demonstrates that the Synthes(USA) Hybrid External Fixator Modifications is substantiallyequivalent to other legally marketed devices. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2008
Synthes (USA) % Ms. Jill Sherman 1302 Wrights Lane East West Chester, PA 19380
Re: K073135
Trade/Device Name: Synthes (USA) Hybrid External Fixator Modifications Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II
Product Code: LXT Dated: January 9, 2008 Received: January 10, 2008
Dear Ms. Jill Sherman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is 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 device, 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 device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device 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 device complies 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 - Ms. Jill Sherman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SYNTHES®
Page I of l
Indications for Use
510(k) Number (if known):
Device Name: Synthes (USA) Hybrid External Fixator Modifications
Indications for Use:
Fixation of proximal and/or distal tibial fractures, with or without extension into the tibial shaft.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
14073135 Cpg 11)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchup
(Division Sign-6 Iff) Division of General, Restorative, and Neurological Devices
510(k) Number K073135
§ 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.