(219 days)
No
The document describes a mechanical implant for hip hemiarthroplasty and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a hip hemiarthroplasty system used to treat degenerative joint diseases and fractures, which falls under the definition of a therapeutic device as it treats and corrects medical conditions.
No
The device is an orthopedic implant for hip hemiarthroplasty, not a tool used to diagnose medical conditions or diseases.
No
The device description clearly states it consists of physical components (CoCr alloy shell, polyethylene bearing insert, retaining ring, CoCr alloy femoral heads) and instrumentation for implantation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for treating various hip joint conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is a physical implant (bipolar head system) used in surgery. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies listed focus on the mechanical and biological properties of the implant (pull out, range of motion, endotoxins), not on diagnostic accuracy or analytical performance related to biological samples.
Therefore, the SurgTech Bipolar Head system is a medical device, specifically a surgical implant, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SurgTech Bipolar Head system is intended for use for cases of: • Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia. - · Inflammatory degenerative joint disease such as rheumatoid arthritis. - Correction of function deformity. - · Revision procedures where other treatments or devices have failed. · Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Product codes
KWY
Device Description
The SurgTech Bipolar Head System is used for hip hemiarthroplasty in skeletally mature individuals. The system consists of a CoCr alloy shell (38-58mm outer diameters), a polyethylene bearing insert (22mm and 28mm inner diameters) and retaining ring, and CoCr alloy femoral heads (22mm and 28mm) in various offsets. Instrumentation necessary for proper implantation is also included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
skeletally mature individuals.
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 testing: The subject devices were evaluated for the following performance characteristics: - Femoral Head/Bipolar Liner Pull Out/Lever Out - Femoral Head/Femoral Stem Pull Off - Range of Motion - Bacterial endotoxins. Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K931655, K152439, K800207, K855231
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.
0
SurgTech, Inc., % Kellen Hills Quality and Regulatory Consultant Orchid Design 4600 E Shelby Drive Memphis. Tennessee 38118
June 14, 2018
Re: K173455
Trade/Device Name: SurgTech Bipolar Head System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip Joint Femoral (Hemi-Hip) Metal/Polymer Cemented Or Uncemented Prosthesis Regulatory Class: Class II Product Code: KWY Dated: May 2, 2018 Received: May 7, 2018
Dear Kellen Hills:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
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) K173455
Device Name
SurgTech Bipolar Head System
Indications for Use (Describe) The SurgTech Bipolar Head system is intended for use for cases of:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- · Inflammatory degenerative joint disease such as rheumatoid arthritis.
- Correction of function deformity.
- · Revision procedures where other treatments or devices have failed.
· Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
| 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) |
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K173455 Page 1/2
| (a)(1) | Submitted By: | SurgTech, Inc.
24600 Center Ridge Road, Suite 195
Westlake, OH 44145 |
|--------|------------------------------------|----------------------------------------------------------------------------|
| | Phone: | 440-899-2922 |
| | Date: | June 8, 2018 |
| | Contact Persons | |
| | Primary: | Kellen Hills (Orchid Design Consulting)
901-433-1990 |
| | Secondary: | Brian Hewko (SurgTech, Inc.) |
| (a)(2) | Proprietary Name:
Common Name: | SurgTech Bipolar Head System
Bipolar Hip Prosthesis |
| | Classification Name and Reference: | 21CFR 888.3390 - Hip Joint femoral (Hemi- |
| | | Hip) Metal/Polymer Cemented or |
| | | Uncemented Prosthesis |
| | Product Code: | KWY |
| (a)(3) | Predicate Devices: | |
| | Primary: | J&J ORTHOPAEDICS-PFC BIPOLAR (K931655) |
| | Additional: | United Orthopedic-U2 BIPOLAR (K152439); |
| | Additional: | Stryker-UHR Bipolar (K800207); |
| | Additional: | Howmedica - CENTRAX (K855231) |
*No predicate has been subject to a design related recall.
(a)(4) Device Description:
Reference:
The SurgTech Bipolar Head System is used for hip hemiarthroplasty in skeletally mature individuals. The system consists of a CoCr alloy shell (38-58mm outer diameters), a polyethylene bearing insert (22mm and 28mm inner diameters) and retaining ring, and CoCr alloy femoral heads (22mm and 28mm) in various offsets. Instrumentation necessary for proper implantation is also included.
SurgTech-MALUC (K162125);
28mm femoral heads as well as all femoral stems used in conjunction with the SurgTech Bipolar Head System were cleared previously in K162125.
The purpose of this submission is to gain initial marketing authorization in the United States.
Indications for Use: (a)(5)
The SurgTech Bipolar Head system is intended for use for cases of:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.
- Inflammatory degenerative joint disease such as rheumatoid arthritis.
- Correction of function deformity.
- Revision procedures where other treatments or devices have failed.
4
- Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
- (a)(6) Comparison of Technological Characteristics:
The SurgTech Bipolar Head system is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, packaging, sterilization and mechanical performance. The technological characteristics do not raise any new questions of safety and efficacy.
(b)(1) Non-clinical testing:
The subject devices were evaluated for the following performance characteristics:
- Femoral Head/Bipolar Liner Pull Out/Lever Out
- Femoral Head/Femoral Stem Pull Off
- Range of Motion
- Bacterial endotoxins
(b)(2) Clinical testing:
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
(b)(3) Conclusions:
Based on the information provided in this premarket notification, we believe that the subject SurgTech Bipolar Head system demonstrates substantial equivalence to the identified predicate devices.