(77 days)
The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
MEMOMETAL FIXOS SCREWS are single-use bone fixation appliances intended to be permanently implanted. Screws are cannulated compressive screws made of titanium alloy (Ti - 6Al -4V ELI) and snap-off screws made of titanium alloy (alloy (Ti - 6Al -4V ELI)
The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conforms to ASTM F543-02 (Sections A1, A2, A3) | The MEMOMETAL FIXOS Screws conform to ASTM F543-02 Standard Specification and Test Methods for Metallic Bone screw (Section A1, A2 and A3). |
| Conforms to ISO 5832-3 | The MEMOMETAL FIXOS Screws conform to ISO 5832-3 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy. |
| Substantially equivalent to predicate devices (K962233, K962236) in: | The MEMOMETAL FIXOS Screws are substantially equivalent to their predicate devices (LANDOS CANNULATED BONE SCREW and TWIST-OFF SCREW) in: |
| - Intended Use & Indications for Use | - Intended Use & Indications for Use (Same) |
| - Material | - Material (Same - titanium alloy (Ti - 6Al -4V ELI)) |
| - Design | - Design (Similar, minor differences do not raise new questions of safety and effectiveness) |
| - Function | - Function (Similar, minor differences do not raise new questions of safety and effectiveness) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes performance testing against established industry standards (ASTM F543-02 and ISO 5832-3) and a claim of substantial equivalence to predicate devices.
- Sample Size for Test Set: The document does not specify the sample size for the mechanical performance tests conducted to meet ASTM and ISO standards. These standards typically define the minimum sample sizes for various tests.
- Data Provenance: Not explicitly stated as country of origin, but the company is based in France (MEMOMETAL TECHNOLOGIES, 35170 BRUZ - France). The testing would have been conducted to international standards. The document only mentions performance data without specifying if it was a retrospective or prospective study on human subjects; it appears to be laboratory-based engineering performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information is not applicable to the provided 510(k) summary. The "ground truth" for this device is based on objective engineering and material science standards (ASTM and ISO) and comparison to predicate devices, not on expert clinical interpretation of data that typically requires human "ground truth" establishment.
4. Adjudication Method for the Test Set
Not applicable. As the performance data relies on objective engineering and material standards, there is no need for an adjudication method in the context of clinical interpretation, which is what "adjudication method" typically refers to.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided document does not mention any MRMC comparative effectiveness study. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data. The FIXOS Screws are implantable bone fixation devices, and their performance is assessed through mechanical testing and material conformance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical medical implant (bone screw), not a software algorithm. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Objective Engineering Standards: Conformance to ASTM F543-02 (Standard Specification and Test Methods for Metallic Bone screw) and ISO 5832-3 (Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy). These standards define test methods and acceptance criteria for material properties and mechanical performance.
- Predicate Device Equivalence: The comparison of material, design, and function to previously legally marketed predicate devices (LANDOS CANNULATED BONE SCREW and TWIST-OFF SCREW) establishes the basis for demonstrating safety and effectiveness for a new device claiming substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The manufacturing process and design are based on established engineering principles and materials.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, there is no "training set" for this device.
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510k Premarket Notification FIXOS SCREWS MEMOMETAL TECHNOLOGIES
(1622)
SECTION 5: 510(K) SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 2 1 2007
As required by section 807.92(c)
| Submitter | MEMOMETAL TECHNOLOGIES |
|---|---|
| Campus de Ker Lann - Rue Blaise Pascal | |
| 35170 BRUZ - France | |
| Phone : + 33 (0)2 99 05 59 69 | |
| Fax :+ 33 (0)2 99 05 95 62 | |
| Contacts | Gilles AUDIC Quality Manager |
| Bernard PRANDI General Manager | |
| e-mail: gilles.audic@memometal.com | |
| bernard.prandi@memometal.com | |
| Preparation date | December 19, 2006 |
| Trade Name | MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-Fix) |
| Common Name | FIXOS Screws |
| Classification Name | Screw, Fixation, Bone |
| Legally marketed | K962233 LANDOS twist-off screw (LANDOS acquired by |
| predicate devices | DEPUY Inc). |
| K962236 LANDOS Scarf thread-head screw (LANDOS | |
| acquired by DEPUY Inc) | |
| Description | MEMOMETAL FIXOS SCREWS are single-use bone fixation |
| appliances intended to be permanently implanted. Screws are | |
| cannulated compressive screws made of titanium alloy (Ti - | |
| 6Al -4V ELI) and snap-off screws made of titanium alloy (alloy | |
| (Ti - 6Al -4V ELI) |
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510k Premarket Notification FIXOS SCREWS MEMOMETAL TECHNOLOGIES
KOF 0039 (2 g 2)
| Intended Use &Indication for use | The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are indicated for fixing and stabilizing the electiveosteotomies of the mid-foot bones and the metatarsal andphalanges of the foot only. |
|---|---|
| Performance data | The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) conform to ASTM F543-02 Standard Specification andTest Methods for Metallic Bone screw (Section A1, A2 andA3) and to ISO 5832-3 Implants for surgery - Metallicmaterials - Part 3: Wrought titanium 6-aluminium 4-vanadiumalloy. |
| Substantial equivalence | THE MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-FIX) are substantially equivalent to their predicate devicesLANDOS CANNULATED BONE SCREW and TWIST-OFFSCREW in terms of intended use and indications for use,material, design and function. Any minor differences betweenthese two devices do not raise new questions of safety andeffectiveness. |
:
:
- The state of the state
Page 12
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
Memometal Technologies % Mr. Gilles Audic Quality Manager Rue Blaise Pascal Campus De Kerr Lann Bruz, France F35170
MAR 2 1 2007
Re: K070039
Trade/Device Name: Memometal Fixos Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 28, 2006 Received: January 03, 2007
Dear Mr. Audic:
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. Gilles Audic
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Barbara Bouchard
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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INDICATIONS FOR USE
K020039 510(k) Number (if known): Device Name: MEMOMETAL FIXOS® SCREWS Indications for Use:
- The MEMOMETAL FIXOS Screws (S-Fix / C-Fix / P-Fix & W-Fix) are indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
Prescription Use > (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Soubare Brelup
(Division Sign-Off)
Division of General, Restorative, and New of General, Resto
and Neurological Devices
510(k) Number K070039
§ 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.