(156 days)
Not Found
No
The document describes a system of bone plates and screws for fracture fixation. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The focus is on the physical components and their compatibility.
Yes
The device is intended for fracture fixation and reconstructive procedures, which are therapeutic interventions.
No
The device is a surgical implant intended for fracture fixation. The document describes its intended use for various bone fractures, its components (plates and screws), and compatibility with other plating systems. It does not mention any diagnostic function.
No
The device description explicitly states that the system includes anatomically contoured monoaxial locking plates, screws, and blind screws, which are physical hardware components intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "long bone fracture fixation" and lists various types of fractures and bone conditions it is used to treat. This is a surgical implant used in vivo (within the body) to stabilize bone.
- Device Description: The description details plates, screws, and their materials, all of which are components of surgical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
The device is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
AxSOS 3 Ti is intended for long bone fracture fixation Indications include: Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures Non-unions and malunions Normal and osteopenic bone Osteotomies Periprosthetic fractures of the femur and proximal tibia. The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of: Periprosthetic fractures Diaphyseal and metaphyseal areas of long bones in pediatric patients The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis Screws are used either to fasten plates . or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, Tbuttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The AxSOS 3 Ti system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws. The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirshner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components come sterile and non-sterile.
The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set consists of plates and screws for fixation of fractures of the cortical and metaphyseal area of the long bone as well as fracture of the pelvis. The implant set is available in either in stainless steel (316 L) or titanium alloy (Ti6Al4V).
This submission is not intended to introduce any new implants into the system, but rather to demonstrate compatibility between the AxSOS 3 Ti system (K153379) and several of the titanium screw/plate components found in the Stryker Plating System (SPS) most recently cleared in K060798. The AxSOS 3 Ti plates and screws are manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and available sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones (Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular), femur, proximal tibia, scapula, pelvis, fibula, metatarsals, metacarpals, radius, ulna, distal humerus, clavicle, distal radius, calcaneus, lateral clavicle, proximal humerus.
Indicated Patient Age Range
Normal and osteopenic bone, pediatric patients.
Intended User / Care Setting
Prescription Use
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)
Bench testing and an engineering analysis were provided to demonstrate compatibility between components. Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2017
Stryker GmbH Irene Bacalocostantis Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K162439 Trade/Device Name: AxSOS 3 Ti; Stryker Plating 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: January 4, 2017 Received: January 5, 2017
Dear Irene Bacalocostantis:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
(page 1 of 2) K162439
Device Name AxSOS 3 Ti
Indications for Use (Describe)
AxSOS 3 Ti is intended for long bone fracture fixation Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
- · Non-unions and malunions
- · Normal and osteopenic bone
- · Osteotomies
- · Periprosthetic fractures of the femur and proximal tibia.
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- · Periprosthetic fractures
- · Diaphyseal and metaphyseal areas of long bones in pediatric patients
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
K162439 (page 2 of 2)
Device Name
Stryker Plating System
Indications for Use (Describe)
SPS Small Fragment Set The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis of the diaphysis of the following:
- · One third tubular plate: fibula, metatarsals, metacarpals
- · Fibular plate: fibula
- · Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle
- · Oblique T-plate: distal radius
- · T-plate: distal radius, calcaneus, lateral clavicle
- · Cloverleaf plate: proximal humerus, distal tibia
- · Calcaneal plate: calcaneus
· Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set The Basic Fragment Set is in long bone fracture fixation. Reconstruction plates. wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the fibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| Proprietary Name: | AxSOS 3 Ti
Stryker Plating System |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Plates
Bone
Screws |
| Regulation Number &
Regulation Description: | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances and accessories. |
| | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Product Code: | HRS (Plate, Fixation, bone)
HWC (Screw, Fixation, Bone/Washer) |
| Device Class: | Class II |
| Sponsor: | Stryker GmbH
Bohnackerweg 1
2545 Selzach / Switzerland |
| Contact Person: | Irene Bacalocostantis Ph.D.
Sr. Regulatory Affairs
Specialist 325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-6797 |
| Date Prepared: | February 2, 2017 |
| Predicate Devices: | AxSOS 3 Ti (K153379)
Stryker Plating System (K060798) |
5
Description
The AxSOS 3 Ti system includes anatomically contoured monoaxial locking plates, as well as screws and blind screws. The plates have been designed with holes that can accommodate either locking or non-locking screws, and also include holes for suture and Kirshner wires (K-wires). The screws come in 3 types (locking, cortical, and cancellous) and are available in several different diameters. All implantable components come sterile and non-sterile.
The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set consists of plates and screws for fixation of fractures of the cortical and metaphyseal area of the long bone as well as fracture of the pelvis. The implant set is available in either in stainless steel (316 L) or titanium alloy (Ti6Al4V).
This submission is not intended to introduce any new implants into the system, but rather to demonstrate compatibility between the AxSOS 3 Ti system (K153379) and several of the titanium screw/plate components found in the Stryker Plating System (SPS) most recently cleared in K060798. The AxSOS 3 Ti plates and screws are manufactured from titanium alloy (Ti6Al4V) per ASTM F136 and available sterile and non-sterile.
AxSOS 3 Ti
Indications For Use
AxSOS 3 Ti is intended for long bone fracture fixation Indications include:
- Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures .
- Non-unions and malunions ●
- Normal and osteopenic bone ●
- Osteotomies ●
- Periprosthetic fractures of the femur and proximal tibia. .
The AxSOS 3 Ti Waisted Compression Plates are also indicated for fracture fixation of:
- Periprosthetic fractures ●
- Diaphyseal and metaphyseal areas of long bones in pediatric patients ●
The 4mm Waisted Compression Plate indications also include fixation of the scapula and the pelvis.
6
Stryker Plating System
Indications for Use:
SPS Small Fragment Set The Stryker® Plating System,
Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following:
- One third tubular plate: fibula, metatarsals, metacarpals ●
- Fibular plate: fibula ●
- Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle ●
- Oblique T-plate: distal radius ●
- T-plate: distal radius, calcaneus, lateral clavicle ●
- Cloverleaf plate: proximal humerus, distal tibia
- Calcaneal plate: calcaneus ●
- Reconstructive plate: humerus, pelvis Screws are used either to fasten plates . or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, Tbuttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
Summary of Technologies
There are no changes to the design or technological characteristics of the AxSOS 3 Ti system implants, nor in the Stryker Plating System.
Non-Clinical Testing
Bench testing and an engineering analysis were provided to demonstrate compatibility between components.
Bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was used for pyrogenicity testing to achieve an Endotoxin limit of ‹ 20EU/Device.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
There have not been any changes or component additions to the AxSOS 3 Ti system. A bench testing and engineering analysis show that several of the plate and screw components in the AxSOS 3 Ti and Stryker Plating System are cross-compatible. The cross-compatibility between the AxSOS 3 Ti System and Stryker Plating System are found in the operative technique guides.