(77 days)
No
The 510(k) summary describes a traditional orthopedic plating system for fracture fixation and osteotomies. There is no mention of AI or ML in the intended use, device description, or performance studies. The submission focuses on adding a pediatric indication to existing components and demonstrating substantial equivalence through mechanical testing.
Yes
The device is described as an "internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies," which directly addresses a therapeutic purpose in treating bone conditions.
No
Explanation: The device, the Stryker AxSOS™ Small Fragment Plating System and Basic Fragment Plating System, is intended for "internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies." This describes a surgical implant used for treatment, not for diagnosing a condition.
No
The device description and intended use clearly describe a system of physical plates, screws, and inserts used for internal fixation of bone fractures and osteotomies. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies." This describes a surgical implant used to treat bone injuries.
- Device Description: The description talks about "plates, screws and inserts" which are components of a surgical implant system.
- Performance Studies: The performance studies focus on "compression fatigue testing" and "fatigue resistance," which are relevant to the mechanical properties of a surgical implant, not an in vitro diagnostic test.
- No mention of in vitro testing: There is no mention of analyzing samples (like blood, urine, tissue) outside of the body, which is the defining characteristic of an IVD.
Therefore, the Stryker AxSOS™ Small Fragment Plating System and Basic Fragment Plating System are surgical implants, not IVDs.
N/A
Intended Use / Indications for Use
The Stryker AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following:
In Adults:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, fibula, distal humerus, clavicle
- . 4mm Locking Insert
- . 4mm Locking Screws
- 3.5mm Cortical Screws
- . 3mm One Third Tubular Plate - fibula, metatarsals, metacarpals
- . 4mm Reconstruction Plate - humerus, pelvis
In Pediatrics:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, distal humerus, clavicle .
- . 4mm Locking Insert
- 4mm Locking Screws .
- 3.5mm Cortical Screws
The Stryker AxSOS™ Basic Fragment Plating System is intended for internal fixation, stabilization and support of long bone fractures as well as bone fixation osteotomies in the following:
In Adults:
- . 5mm Waisted Compression Plate - Broad -femur, tibia, humerus, pelvis
- . 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus, pelvis
- . 5mm Locking Insert
- . 5mm Locking Screws
- . 4.5mm Cortical Screws
- . 5mm Reconstruction Plate - femur, tibia, humerus, pelvis
In Pediatrics:
- 5mm Waisted Compression Plate -- Broad -femur, tibia, humerus .
- . 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus
- . 5mm Locking Insert
- . 5mm Locking Screws
- 4.5mm Cortical Screws
Product codes
87 HRS, 87 HWC
Device Description
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to add the pediatric indication to a specific subset of plates, screws and inserts of the previously cleared Stryker Plating System (K060514). The components from the previously cleared system, some of which carry the pediatric indication, will make-up the system to be marketed as the AxSOS™ Locking Plate System. The indications for use will clarify which components will include the pediatric indication.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Radius, ulna, distal tibia, fibula, distal humerus, clavicle, metatarsals, metacarpals, humerus, pelvis, femur, tibia.
Indicated Patient Age Range
Adults, Pediatrics
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed for the subject plates, screws and inserts to determine substantial equivalence. As there are no additional design, process, material or performance characteristic changes, no general tests for verification and validation are necessary. However, an additional compression fatigue testing was conducted for the subject plates, screws and insert to evaluate the fatigue resistance in long-term pediatric use. The testing demonstrated that the AxSOS™ Locking Plate Systems are substantially equivalent to devices currently cleared for market with pediatric indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Page 1/4
| K | 112926 |
|---|---|
| DEC | 1 9 2011 |
510(k) Summary of Safety and Effectiveness
| Proprietary Name: | AxSOST™ Locking Plate System |
|---|---|
| Common Name: | Bone plates and screws |
| Classification Name and Reference: | Single/multiple component metallic bone fixation appliances and accessories |
- 21 CFR §888.3030;
Smooth or threaded metallic bone fixation fastener - 21 CFR §888.3040 |
| Regulatory Class: | Class II |
| Product Codes: | 87 HRS: Plate, Fixation, Bone;
87 HWC: Screw, Fixation, Bone |
| For Information contact: | Kelly Kucharczyk, Regulatory Affairs Associate
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-6455 Fax: (201) 831-3461 |
| Date Prepared: | September 23, 2011 |
Description:
This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to add the pediatric indication to a specific subset of plates, screws and inserts of the previously cleared Stryker Plating System (K060514). The components from the previously cleared system, some of which carry the pediatric indication, will make-up the system to be marketed as the AxSOS™ Locking Plate System. The indications for use will clarify which components will include the pediatric indication.
1
K11 2926
Page 2/4
Intended Use:
The Stryker AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following:
In Adults:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, fibula, distal • humerus, clavicle
- 4mm Locking Insert .
- 4mm Locking Screws .
- . 3.5mm Cortical Screws
- 3mm One Third Tubular Plate fibula, metatarsals, metacarpals .
- 4mm Reconstruction Plate humerus, pelvis .
In Pediatrics:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, distal humerus, . clavicle
- 4mm Locking Insert .
- . 4mm Locking Screws
- . 3.5mm Cortical Screws
The Stryker AxSOS™ Basic Fragment Plating System is intended for internal fixation, stabilization and support of long bone fractures as well as bone fixation osteotomies in the following:
In Adults:
- 5mm Waisted Compression Plate Broad -femur, tibia, humerus, pelvis •
- 5mm Waisted Compression Plate Narrow femur, tibia, humerus, pelvis .
- ◆ 5mm Locking Insert
- 5mm Locking Screws
- . 4.5mm Cortical Screws
- 5mm Reconstruction Plate femur, tibia, humerus, pelvis .
In Pediatrics:
- 5mm Waisted Compression Plate Broad -femur, tibia, humerus .
- 5mm Waisted Compression Plate Narrow femur, tibia, humerus .
- . 5mm Locking Insert
- . 5mm Locking Screws
- 4.5mm Cortical Screws .
2
11 2926
Page 3/4
Indications:
The Stryker AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following:
In Adults:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, fibula, distal . humerus, clavicle
- 4mm Locking Insert .
- 4mm Locking Screws .
- 3.5mm Cortical Screws .
- 3mm One Third Tubular Plate fibula, metatarsals, metacarpals .
- 4mm Reconstruction Plate humerus, pelvis .
In Pediatrics:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, distal humerus, . clavicle
- . 4mm Locking Insert
- . 4mm Locking Screws
- 3.5mm Cortical Screws .
The Stryker AxSOS™ Basic Fragment Plating System is intended for internal fixation, stabilization and support of long bone fractures as well as bone fixation osteotomies in the following:
In Adults:
- 5mm Waisted Compression Plate Broad-femur, tibia, humerus, pelvis .
- . 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus, pelvis
- 5mm Locking Insert .
- . 5mm Locking Screws
- 4.5mm Cortical Screws .
- 5mm Reconstruction Plate femur, tibia, humerus, pelvis .
In Pediatrics:
- 5mm Waisted Compression Plate Broad -femur, tibia, humerus .
- 5mm Waisted Compression Plate Narrow femur, tibia, humerus .
- . 5mm Locking Insert
- 5mm Locking Screws .
- 4.5mm Cortical Screws .
Summary of Technologies:
Device comparisons showed that the proposed device is substantially equivalent in intended use, design, materials and performance characteristics to the following predicate devices:
K082807- Synthes 3.5 and 4.5mm Locking Compression Plate (LCP) System K060514- Stryker Locked Plating System
3
ll 2926
Page 4/4
Non-Clinical Testing:
Non-clinical laboratory testing was performed for the subject plates, screws and inserts to determine substantial equivalence. As there are no additional design, process, material or performance characteristic changes, no general tests for verification and validation are necessary. However, an additional compression fatigue testing was conducted for the subject plates, screws and insert to evaluate the fatigue resistance in long-term pediatric use. The testing demonstrated that the AxSOS™ Locking Plate Systems are substantially equivalent to devices currently cleared for market with pediatric indications.
Clinical Testing:
Clinical testing was not required for this submission.
Conclusion:
The AxSOS™ Locking Plate System is substantially equivalent to the predicate devices identified in this premarket notification.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring three parallel lines that curve and converge.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Corporation % Ms. Kelly Kucharczyk 325 Corporate Drive Mahwah, New Jersey 07430
DEC 1 9 2011
Re: K112926
Trade/Device Name: AxSOS™ Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 29, 2011 Received: October 3, 2011
Dear Ms. Kucharczyk:
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 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
5
Page 2- Ms. Kelly Kucharczyk
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Mullan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: AxSOSTM Locking Plate System
The Stryker AxSOS™ Small Fragment Plating System is intended for internal fixation, stabilization and support of fractures as well as bone fixation after osteotomies in the following:
In Adults:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, fibula, distal humerus, clavicle
- . 4mm Locking Insert
- . 4mm Locking Screws
- 3.5mm Cortical Screws
- . 3mm One Third Tubular Plate - fibula, metatarsals, metacarpals
- . 4mm Reconstruction Plate - humerus, pelvis
In Pediatrics:
- 4mm Waisted Compression Plate radius, ulna, distal tibia, distal humerus, clavicle .
- . 4mm Locking Insert
- 4mm Locking Screws .
- 3.5mm Cortical Screws
The Stryker AxSOS™ Basic Fragment Plating System is intended for internal fixation, stabilization and support of long bone fractures as well as bone fixation osteotomies in the following:
In Adults:
- . 5mm Waisted Compression Plate - Broad -femur, tibia, humerus, pelvis
- . 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus, pelvis
- . 5mm Locking Insert
- . 5mm Locking Screws
- . 4.5mm Cortical Screws
- . 5mm Reconstruction Plate - femur, tibia, humerus, pelvis
In Pediatrics:
- 5mm Waisted Compression Plate -- Broad -femur, tibia, humerus .
- . 5mm Waisted Compression Plate - Narrow - femur, tibia, humerus
- . 5mm Locking Insert
- . 5mm Locking Screws
- 4.5mm Cortical Screws
Prescription Use Over-The-Counter 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)
-
- 13.12 1
Mark Mellekson
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112926