(61 days)
The AxSOS™ Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
This Special 510(k) submission is a line extension to address modifications made to the AxSOS™ Locking Plate System which was cleared in K061012. This line extension is to add four femoral long plates to the existing size range of the AxSOS™ Locking Plate System. These monoaxial long plates will be known as AxSOS™ Distal Lateral Femur TS (Threaded Shaft) Long Plates and will be available in two lengths in left and right configurations.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K061012) in: | Demonstrated substantial equivalence in: |
| - Intended Use | - Intended Use (Fractures of the Distal Femur) |
| - Design | - Design (Monoaxial Plates) |
| - Material | - Material (Stainless Steel) |
| - Operational Principles | - Operational Principles (as a bone fixation device) |
| Static strength | Static strength testing demonstrated substantial equivalence |
| Fatigue strength | Fatigue strength testing demonstrated substantial equivalence |
| Risk analysis (ISO 14971:2007 compliance) | Risk analysis was performed according to ISO 14971:2007 |
Note: The document explicitly states that the "AxSOS™ Distal Lateral Femur TS Long Plates are substantially equivalent to the AxSOS™ Distal Lateral Femur TS Plates of the AxSOS™ Locking Plate System cleared under K061012 in regards to intended use, design, materials, and operational principles as a bone fixation device." The specific performance metrics for static and fatigue strength are stated as having "demonstrated the subject plates are substantially equivalent to the predicate devices" but no numerical acceptance ranges or specific values are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions "Static strength as well as fatigue strength testing" for the subject device. It does not specify a sample size for these tests, nor does it describe them as a "test set" in the context of clinical or image-based studies. The data provenance is also not mentioned (e.g., country of origin, retrospective/prospective), as these are in vitro mechanical tests, not human data studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the provided document describes a 510(k) submission for a medical device (bone fixation plates) based on mechanical testing and substantial equivalence, not a study involving human readers or image analysis requiring expert ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not conducted. This document describes a mechanical device substantially equivalent to a predicate, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. This document pertains to a physical medical device.
7. The Type of Ground Truth Used
For the mechanical testing (static and fatigue strength), the "ground truth" would be established by standardized engineering testing protocols and measurement instruments. There is no mention of expert consensus, pathology, or outcomes data, as these are material science evaluations.
8. The Sample Size for the Training Set
There is no mention of a "training set" in this document. The submission relies on demonstrating substantial equivalence through design comparisons and mechanical testing, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set mentioned.
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OCT
1 2012
510(k) Summary of Safety and Effectiveness
AxSOS™ Locking Plate System
Proprietary Name:
AxSOS™ Locking Plate System
Common Name:
Bone plates
Classification Name and Reference:
Single/multiple component metallic bone fixation appliances and accessories, 21 CFR $888.3030
Regulatory Class:
Product Codes:
Predicate Devices:
For Information contact:
Class II
87 HRS: Plate, Fixation, Bone
AxSOS™ Locking Plate System
Estela Celi Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. NJ 07430 Phone: (201) 831-6461 Fax: (201) 831-6038 Estela.Celi(@stryker.com
Date Prepared:
September 27, 2012
Description
This Special 510(k) submission is a line extension to address modifications made to the AxSOS™ Locking Plate System which was cleared in K061012. This line extension is to add four femoral long plates to the existing size range of the AxSOS™ Locking Plate System. These monoaxial long plates will be known as AxSOS™ Distal Lateral Femur TS (Threaded Shaft) Long Plates and will be available in two lengths in left and right configurations.
Intended Use
The AxSOS™ Distal Lateral Femur TS Long Plates line extension does not alter the intended use of the predicate AxSOS™ Locking Plate System as cleared in K061012. The indications for use for the subject plates are provided below.
Indications
The AxSOS™ Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
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Substantial Equivalence:
The AxSOS™ Distal Lateral Femur TS Long Plates are substantially equivalent to the AxSOS™ · Distal Lateral Femur TS Plates of the AxSOS™ Locking Plate System cleared under K061012 in regards to intended use, design, materials, and operational principles as a bone fixation device.
| AxSOSTM Locked Plating Comparison of Subject to Predicate | ||
|---|---|---|
| Subject DeviceAxSOSTM Distal Lateral FemurTS Long Plates | Predicate DeviceAxSOSTM Distal LateralFemur TS Plates | |
| 510(k) | Pending | K061012 |
| Intended Use | Fractures of the Distal Femur | Fractures of the Distal Femur |
| Design | Monoaxial Plates | Monoaxial Plates |
| Material | Stainless Steel | Stainless Steel |
| Plate Sizes | 2 lengths/18-20 hole plates | 7 lengths/4-16 hole plates |
Summary of Non-Clinical Testing and Evaluation
- Risk analysis was performed according to the requirements of ISO 14971:2007 "Medical Devices-Application of risk management to medical devices." Records of the risk analysis process are retained in the design history file. Static strength as well as fatigue strength testing has demonstrated the subject plates are substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
1 2012
Howmedica Osteonics Corporation % Ms. Estella Celi Regulatory Affairs 325 Corporate Drive Mahwah. New Jersey 07430
Re: K122308
Trade/Device Name: AxSOS™ Distal Lateral Femur TS Long Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and acccesories Regulatory Class: II
Product Code: HRS Dated: September 11, 2012 Received: September 12, 2012
Dear Ms. Celi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Estella Celi
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
sincerely yours,
Kuma
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX E-1
Indication for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: AxSOSTM Distal Lateral Femur TS Long Plates
Indications for Use:
The AxSOS™ Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.
Asit
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122308
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.