(98 days)
No
The document describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the treatment of a hyperpronated foot and stabilization of the subtalar joint, which are therapeutic purposes.
No
The device is an implant designed for treatment and stabilization, not for diagnosing conditions. Its purpose is to physically address a medical issue rather than to identify or characterize it.
No
The device description clearly states it is a "threaded implant" manufactured from Ti-6A1-4V, indicating it is a physical hardware device, not software.
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 a physical condition (hyperpronated foot and subtalar joint stabilization). This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a threaded implant made of titanium, designed for surgical insertion into a joint. This is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The STS screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.
- Severely pronated foot;
- Walking intemperance;
- Calcaneal stance position greater than 50;
- Manually correctable deformities;
- Mid-tarsal breech (arch pain);
- Forefoot varus greater than 10°.
Product codes
HWC
Device Description
The Subtalar Spacer System (STS) a threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint. It is manufactured from Ti-6A1-4V per ASTM F136 and is available in 6 sizes. STS has a center cannula design for use with a guide wire to facilitate proper placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subtalar joint, foot
Indicated Patient Age Range
Not Found
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
Testing rationales were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system. The safety and effectiveness of the STS implant is adequately supported within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K032682-Ortho-Pro STS Screw, K070441-Metasurg Subtalar Implant
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated Ms. Tara Conrad Regulatory Affair Specialist II 1023 Cherry Road Memphis, Tennessee 38117
May 8, 2015
Re: K150213
Trade/Device Name: Subtalar Spacer System (STS) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: January 21, 2015 Received: January 30, 2015
Dear Ms. Conrad:
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. Isting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Tara Conrad
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 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" (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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150213
Device Name
Subtalar Spacer System (STS)
Indications for Use (Describe)
The STS screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.
- · Severely pronated foot;
- · Walking intemperance;
- · Calcaneal stance position greater than 50;
- · Manually correctable deformities;
- · Mid-tarsal breech (arch pain);
- · Forefoot varus greater than 10°.
Type of Use (Select one or both, as applicable)
X] 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 A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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K150213 (page 1/2)
Headquarters Whant Monical TA
023 Cherry Road mohis TN 3811
901867 997 wmt.com
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Subtalar Spacer System (STS).
| | Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|----|------------------------------------|------------------------------------------------------------------------------------------|
| | Date: | May 13, 2015 |
| | Contact Person: | Tara Conrad
Regulatory Affairs Specialist II
Phone: 901-867-4367 Fax: 901-867-4190 |
| 2. | Proprietary Name: | Subtalar Spacer System (STS) |
| | Common Name: | Smooth or threaded metallic bone fixation fastener |
| | Classification Name and Reference: | 21 CFR 888.3040- Class II |
| | Device Product Code, Device Panel: | HWC- Orthopedic |
| 3. | Predicate Device: | K032682-Ortho-Pro STS Screw
K070441-Metasurg Subtalar Implant |
4. Device Description
The Subtalar Spacer System (STS) a threaded implant designed to be inserted between the posterior and middle facets of the subtalar joint. It is manufactured from Ti-6A1-4V per ASTM F136 and is available in 6 sizes. STS has a center cannula design for use with a guide wire to facilitate proper placement.
Intended Use
ડ.
Indications for Use:
The STS implant is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.
- Severely pronated foot; .
- . Walking intemperance;
- o Calcaneal stance position greater than 50;
- o Manually correctable deformities;
Image /page/3/Picture/17 description: The image shows the logo for Wright. The logo consists of two overlapping trapezoids on the left, followed by the word "WRIGHT" in large, bold letters. Below the word "WRIGHT" is the phrase "FOCUSED EXCELLENCE" in smaller letters.
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- Mid-tarsal breech (arch pain); .
- Forefoot varus greater than 10°. .
6. Technological Characteristics Comparison
The STS implant and the legally marketed predicate Ortho-Pro STS Screw have identical indications, have the same overall features, and are identical in material. The two differences are:
-
- Total length
-
- Pitch
7. Substantial Equivalence- Non-Clinical Evidence
Testing rationales were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system. The safety and effectiveness of the STS implant is adequately supported within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices.
8. Substantial Equivalence- Clinical Evidence
N/A
9. Substantial Equivalence- Conclusions
The design characteristics of the subject devices do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent.
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