(87 days)
The Synthes (USA) 2nd Generation Pelvic C-Clamp is intended for emergency stabilization of sacrum fractures or disruptions of the sacroiliac joint with associated circulatory instability.
The Synthes 2nd Generation Pelvic C-Clamp is an emergency stabilization instrument for unstable injuries and fractures of the pelvic ring. It is an external fixation device comprised of four main parts: An inner rail, two outer rails, two upper side arms, and two lower side arms. It utilizes short or long cannulated nails and is stored preassembled.
The provided document describes a medical device, the Synthes (USA) 2nd Generation Pelvic C-Clamp, and its clearance process through the FDA's 510(k) pathway. This pathway establishes substantial equivalence to a legally marketed predicate device rather than independently proving performance against specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is available:
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Acceptance Criteria and Reported Device Performance (Point 1): The document does not list specific, quantifiable acceptance criteria for the device's performance (e.g., a certain force it must withstand, a specific range of motion it must allow/restrict, or clinical outcome measures) nor does it report performance data against such criteria. The 510(k) process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.
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Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set (Points 2-9): These points refer to the design and conduct of a typical clinical or performance study that would generate efficacy or safety data. Since the 510(k) summary focuses on substantial equivalence to a predicate device, it does not describe such a study.
What the document does provide:
- Device Name: Synthes (USA) 2nd Generation Pelvic C-Clamp
- Intended Use: Emergency stabilization of sacrum fractures or disruptions of the sacroiliac joint with associated circulatory instability.
- Classification: Class II device, regulated under 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
- Predicate Device: Synthes (USA) Pelvic C-Clamp. The primary mechanism for clearance is demonstrating "substantial equivalence" to this previously cleared device.
- Regulatory Pathway: 510(k) premarket notification. This pathway does not typically require new clinical studies to demonstrate safety and effectiveness if substantial equivalence can be shown.
In summary, the provided text is a 510(k) summary and FDA clearance letter, which details the regulatory process for a medical device by demonstrating its substantial equivalence to an existing predicate device. It does not include the results of a de novo study designed to establish and meet specific acceptance criteria through performance testing or clinical trials.
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Image /page/0/Picture/1 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized human figure inside of a circle. To the right of the word is a small, superscripted "R" in a circle, indicating that the word is a registered trademark. A horizontal line is located underneath the word.
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| 3.0 | 510(k) Summary | Page | 1 | of 1 | |||
|---|---|---|---|---|---|---|---|
| Sponsor: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(610) 719-5000 | AUG 2 4 2007 | |||||
| Contact: | Angela SilvestriSynthes (USA)1301 Goshen ParkwayWest Chester, PA 19380(484) 356-9728 | ||||||
| Device Name: | Synthes (USA) 2nd Generation Pelvic C-Clamp | ||||||
| Classification: | The classification of the Synthes Pelvic C-Clamp 2nd Generation, asper 21 of the Code of Federal Regulations, Section 888.3040 –Smooth of threaded metallic bone fixation fastener. | ||||||
| Predicate Device: | Synthes (USA) Pelvic C-Clamp | ||||||
| Device Description: | The Synthes 2nd Generation Pelvic C-Clamp is an emergencystabilization instrument for unstable injuries and fractures of thepelvic ring. It is an external fixation device comprised of four mainparts: An inner rail, two outer rails, two upper side arms, and twolower side arms. It utilizes short or long cannulated nails and isstored preassembled. | ||||||
| Intended Use: | The Synthes (USA) 2nd Generation Pelvic C-Clamp is intended foremergency stabilization of sacrum fractures or disruptions of thesacroiliac joint with associated circulatory instability. | ||||||
| SubstantialEquivalence: | Documentation is provided which demonstrates the Synthes (USA)2nd Generation Pelvic C-Clamp to be substantially equivalent toother legally marketed devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) c/o Ms. Angela Silvestri Director, Regulatory Affairs 1301 Goshen Parkway West Chester, PA 19380
AUG 2 4 2007
K071476 Trade/Device Name: 2nd Generation Pelvic C-Clamp Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC Dated: August 3, 2007 Received: August6, 2007
Dear Ms. Silvestri:
Re:
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 -- Mr. Angela Silvestri
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Soubana Bricello
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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line underneath the word. The registered trademark symbol is to the right of the word.
Indications for Use
510(k) Number (if known):
KO71476
Device Name:
2.0
:
Synthes (USA) 2nd Generation Pelvic C-Clamp
Indications for Use:
The Synthes (USA) 2nd Generation Pelvic C-Clamp is intended for emergency stabilization of sacrum fractures or disruptions of the sacroiliac joint with associated circulatory instability.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of I
Clulare Powell
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K071746
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.