(79 days)
The Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.
The Synthes Low-Profile Wrist Fixator consists of frame elements that form a construct intended to treat fractures of the distal radius. The Low-Profile Wrist Fixator provides stabilization of fractures via pins (Schanz screws) inserted proximally and distally to a fracture and connected by an external bridging frame consisting of two Low-Profile Wrist Fixator Clamps - MR Safe, a carbon fiber rod and two protective end caps. The Low-Profile Wrist Fixator is available as a complete sterile assembly.
The provided document describes a medical device, the Synthes (USA) Low-Profile Wrist Fixator, and its clearance through the 510(k) premarket notification process. This process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm-only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Explanation:
The 510(k) submission primarily focuses on demonstrating that the "Synthes (USA) Low-Profile Wrist Fixator" is substantially equivalent to existing, legally marketed predicate devices (Orthofix Penning Wrist Fixator, Synthes (USA) Articulating Distal Radius System, Synthes (USA) 4.0 mm Adjustable Clamp for Distal Radius). Substantial equivalence is typically established by comparing device characteristics such as intended use, technological characteristics, and performance data without requiring new clinical trials if the device is similar enough to predicates.
The document states: "Documentation is provided which demonstrates that the Synthes (USA) Low-Profile Wrist Fixator is substantially equivalent to other legally marketed devices." It also mentions "The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice requirements... labeling, and prohibitions against misbranding and adulteration." This indicates regulatory clearance based on equivalence and adherence to general controls, not on a study proving a novel device meets specific performance acceptance criteria as would be required for innovative devices or those requiring a PMA.
In essence, the 510(k) process is about demonstrating safety and effectiveness by showing similarity to an already approved device, not by independently proving performance against predefined acceptance criteria for a novel device.
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3.0 510(k) Summary
Page ________ of _____________________________________________________________________________________________________________________________________________________________
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380(610) 719-5860 |
|---|---|
| Device Name: | Synthes (USA) Low-Profile Wrist Fixator |
| Classification: | Class II, §888.3030 - Single/multiple component bone fixationappliances and accessories |
| Predicate Devices: | Orthofix Penning Wrist FixatorSynthes (USA) Articulating Distal Radius SystemSynthes (USA) 4.0 mm Adjustable Clamp for Distal Radius |
| Device Description: | The Synthes Low-Profile Wrist Fixator consists of frame elementsthat form a construct intended to treat fractures of the distal radius.The Low-Profile Wrist Fixator provides stabilization of fracturesvia pins (Schanz screws) inserted proximally and distally to afracture and connected by an external bridging frame consisting oftwo Low-Profile Wrist Fixator Clamps - MR Safe, a carbon fiberrod and two protective end caps. The Low-Profile Wrist Fixator isavailable as a complete sterile assembly. |
| Intended Use: | The Synthes Low-Profile Wrist Fixator is intended for stabilizationof fractures of the distal radius. |
| SubstantialEquivalence: | Documentation is provided which demonstrates that the Synthes(USA) Low-Profile Wrist Fixator is substantially equivalent toother legally marketed devices.The term "substantial equivalence" as used in this 510(k)notification is limited to the definition of substantial equivalencefound in the Federal Food, Drug and Cosmetic Act, as amendedand as applied under 21CFR 807, Subpart E under which a devicecan be marketed without premarket approval or reclassification. Adetermination of substantial equivalency under this notification isnot intended to have any bearing whatsoever on the resolution ofpatent infringement suits or any other patent matters. Nostatements related to, or in support of substantial equivalenceherein shall be construed as an admission against interest under theUS Patent Laws or their application by the courts. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2005
Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K051049
K031047
Trade/Device Name: Synthes (USA) Low-Profile Wrist Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: June 21, 2005 Received: June 22, 2005
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainted institution was and starting and in interests a ferenced above and nave determined the arrested predicate devices marketed in interstate for use stated in the encrosule) to regally manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prof to May 26, 1976, the encordance with the provisions of the Federal Food. Drug, devices that have been recure approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act . The and Cosment Act (Act) that do not require approvine controls provisions of the Act. The You may, therefore, market the device, basjoct to the go
general controls provisions of the Act include requirements for annual registration, listing of the general controls provisions of the free 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 II your device is classified (soc aboro) ins Existing major regulations affecting your device can
may be subject to such additional controls. Existing major and considerer may be subject to such additional controllar Extrong may on 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, be found in the Code of I same concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that TDA S Issualled of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a dolorimiations administered by other Federal agencies. You must of any Federal statutes and regulations anning, but not limited to: registration and listing (21 comply with an the Act 3 requirements, mercially, and manufacturing practice requirements as set and CFK Part 807), labeling (21 CFR Part 807), good and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Kathy Anderson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailiering of substantial equivalence of your device to a legally premarket notincation: "The Privating of cation 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 If you desire specific acritor 101-12-1120. Also, please note the regulation entitled, Colliact the Office of Compunation in (21CFR Part 807.97). You may obtain Misblanding by reference to promantsvillities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octoss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mirian Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use
| 510(k) Number (if known): | K051049 |
|---|---|
| --------------------------- | --------- |
Device Name: Synthes (USA) Low-Profile Wrist Fixator
Indications for Use:
The Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.
X Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Styt Purda
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________ KOSTOYG
§ 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.