(119 days)
This device is indicated for use in the fixation of unstable femoral neck fractures.
The Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures is an implantable device to be used in orthopedic trauma procedures. The D.S.S. System For Osteosynthesis of Unstable Femoral Neck Fractures is a hip screw mechanism that allows a natural, weight-bearing compression. The D.S.S. screws can be utilized alone, or in combination with a mini-plate, allowing most flexibility in configurations of osteosynthesis in unstable femoral neck fractures.
This document is a 510(k) summary for the Fixano D.S.S. (Double Sliding Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures. As such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth establishment is not available in this document. The 510(k) process primarily relies on non-clinical data (e.g., mechanical testing, materials characterization) and comparison to legally marketed predicate devices to establish safety and effectiveness.
Here's a breakdown of why this information isn't present in this type of submission:
- Acceptance Criteria & Performance Data: 510(k) submissions typically do not include detailed performance tables from clinical trials with specific acceptance criteria like sensitivity, specificity, or AI-assisted improvement. Instead, they focus on showing that the new device performs as intended and is as safe and effective as a predicate device.
- Clinical Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone): These are elements of a clinical trial designed to assess device performance in human subjects. A 510(k) summary usually relies on bench testing and comparisons to predicate devices, especially for devices like orthopedic implants, where clinical studies may not be required for market clearance if substantial equivalence can be established otherwise.
- Ground Truth: The concept of "ground truth" (e.g., expert consensus, pathology) for clinical performance is not typically a primary focus of a 510(k) submission for orthopedic implants unless a specific clinical study was conducted (which isn't detailed here).
- Training Set Information: This is relevant for AI/ML devices. The Fixano DSS system is a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device. Thus, there is no AI training set.
Summary of available information related to performance/equivalence from the document:
- Intended Use: Fixation and osteosynthesis of unstable femoral neck fractures.
- Technological Characteristics: Hip screw mechanism allowing natural, weight-bearing compression. Can be used alone or with a mini-plate for flexibility in osteosynthesis configurations.
- Substantial Equivalence: Claims substantial equivalence to various existing hip screw systems, including Synthes Sliding Screws (K954757), Dynamic Hip Screw (DHS) (K791619), and Howmedica Plus Compression Hip Screw System Omega (K955306). This implies that the device performs similarly in its intended function to these predicate devices, which are already on the market.
In conclusion, this 510(k) summary does not contain the detailed clinical study information requested because it is a premarket notification for an orthopedic implant seeking clearance based on substantial equivalence, rather than a clinical trial report for an AI-enabled device or a device requiring new clinical performance data.
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MAY 2 2 1997
15 January 1997
510(k) SUMMARY
The 510(k) summary information required by 21 CFR 807.92 is as follows:
- Screw, fixation, bone, or Classification name: A. nail/plate/blade fixation, appliance, a combination, multiple component.
- Hip screw, hip pin, hip screw Common/Usual name: and plate, etc.
- Fixano D.S.S. (Double Sliding Proprietary name: Screws) System For Osteosynthesis of Unstable Femoral Neck Fractures.
- Fixano D.S.S. (Double Substantial equivalence: B. Synthes Sliding Screws) System (K954757), Dynamic Hip Screw (DHS) (K791619), Howmedica Plus Compression Hip Screw System Omega (K955306), and others.
- (Double The Fixano D.S.S. C. description: Device System For Osteosynthesis of Sliding Screws) Neck Fractures Femoral is an Unstable implantable device to be used in orthopedic trauma procedures.
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oded use: System For Intended use: D. Femoral Neck Fractures is intended for use in the fixation and osteosynthesis of unstable femoral neck fractures.
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Technological characteristics: The D.S.S. System E . For Osteosynthesis of Unstable Femoral Neck Fractures is a hip screw mechanism that allows a natural, weight-bearing compression. The D.S.S. screws can be utilized alone, or in combination with a mini-plate, allowing most of osteosynthesis in flexibility configurations of unstable femoral neck fractures.
Submitted, FERGUSON MEDICAL FDA_Establishment Registration Number 2937794
Arank Foutson
Frank Ferguson Official Correspondent
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1997
Frank Ferquson Mr. Official Correspondent Ferquson Medical ... .. .. .. .. .. .. 3407 Bay Avenue Chico, California 95973
Re : K970257 Fixano Double Sliding Screws (D.D.S.) with Intramedullary Nail K970258 Fixano Double Sliding Screws (D.D.S.) and Mini-Plate K970280 Fixano Double Sliding Screws (D.D.S.) and Sid Plate Regulatory Class: II Product Codes: HSB, HRS and HRS Dated: April 15, 1997 Received: April 21, 1997
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). 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 (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in
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Page 2 - Mr. Frank Ferguson
Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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K 9-10258 10(k) Number (If known):
Fixano DSS (Double Sliding Screw) System For Device Name: Osteosynthesis of Unstable Femoral Neck Fractures
Indications For Use:
This device is indicated for use in the fixation of unstable femoral neck fractures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General Restorative Devi 51C(k) Number -------
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.