(27 days)
Not Found
No
The summary describes a mechanical implant for ankle replacement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a total ankle arthroplasty system intended to reduce pain and restore alignment and movement in the ankle joint for patients with severe arthritis or failed previous ankle surgery, which are therapeutic goals.
No
The device described is a total ankle arthroplasty system, which is an implantable medical device used to replace a damaged ankle joint. It is a prosthetic device for treatment, not for diagnosing a condition.
No
The device description explicitly lists hardware components (tibial trays, talar domes, poly inserts, tibial stems, and talar stems) and describes it as a total ankle system, which is a physical implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a Total Ankle Arthroplasty System, which is a surgical implant used to replace a damaged ankle joint. It is intended to be surgically implanted into the patient's body to restore mobility and reduce pain.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any specimens taken from the body. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the INBONE™ Total Ankle System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The INBONE™ Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
The INBONE™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
Product codes (comma separated list FDA assigned to the subject device)
HSN
Device Description
The INBONE™ Total Ankle System consists of tibial trays, talar domes, poly inserts, tibial stems and talar stems.
The design features of the INBONE™ Total Ankle System device modification are substantially equivalent to the design features of the predicate INBONE™ Total Ankle System devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joint
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was shown through fatigue testing. The results of the fatigue test show that the additional size can be expected to perform at least as well as the legally marketed predicate.
The safety and effectiveness of the INBONE™ Total Ankle System additional size is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
Substantial equivalence is shown through fatigue testing. The materials, indications and design features are identical and the subject and predicate differ in overall length, but no new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
DEC 1 4 2010
K10337
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 CRF 807.92. this information serves as a Summary of Safety and Effectiveness for the Use of the INBONE™ Total Ankle System (Device Modification).
| A.1. Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd
Arlington, TN 38002 |
|-----------------------------------|---------------------------------------------------------------------------------------|
| Date: | November 16, 2010 |
| Contact Person: | Kelsey Lee
Regulatory Affairs Specialist II
(901) 290-5909 |
| A.2. Proprietary Name: | INBONE™ Total Ankle System (Device Modification) |
| Common Name: | Ankle Prosthesis |
| Device Classification Regulation: | 21 CFR 888.3110--Class II |
| Device Product Code & Panel: | HSN: Ankle joint metal/polymer semi-constrained cemented prosthesis
87 Orthopedics |
| A.3. Predicate Device: | INBONE™ Total Ankle System (K051023) |
A.4. Device Description
The INBONE™ Total Ankle System consists of tibial trays, talar domes, poly inserts, tibial stems and talar stems.
The design features of the INBONE™ Total Ankle System device modification are substantially equivalent to the design features of the predicate INBONE™ Total Ankle System devices.
A.5. Intended Use
The INBONE™ Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
The INBONE™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
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1
K103374$\frac{2}{2}$
The INBONE™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
The indications are identical to the legally marketed predicate device.
A.6. Technological Characteristics Comparison
The modified INBONE™ Total Ankle System and the legally marketed predicate INBONE™ Total Ankle System have identical indications, utilize the same instruments, and have similar design features.
The device modification in the subject INBONE™ Total Ankle System differs from the legally marketed predicate in the addition of a new size.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence was shown through fatigue testing. The results of the fatigue test show that the additional size can be expected to perform at least as well as the legally marketed predicate.
The safety and effectiveness of the INBONE™ Total Ankle System additional size is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
B.2. Substantial Equivalence - Clinical Evidence
N/A
'
i
.
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through fatigue testing. The materials, indications and design features are identical and the subject and predicate differ in overall length, but no new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DEC 1 4 2010
Wright Medical Technology, Inc. % Ms. Kelsey Lee 5677 Airline Road Arlington, TN 38002
Re: K103374 Trade/Device Name: INBONE Total Ankle System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: I-ISN Dated: November 16, 2010 Received: November 17, 2010
Dear Ms. Lee:
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
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Page 2 - Ms. Kelsey Lee
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/AboutlFDA/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/ReportalProblem/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,
for Peter De
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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Indications for Use
510(k) Number (if known): KID3374
Device Name: INBONE™ Total Ankle System
Indications For Use:
Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
The ankle prosthesis is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
Prescription Use xxx (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 of 1
for M. Melkerm
(Division(Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103374