(27 days)
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.
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.
This document describes a 510(k) premarket notification for a modified INBONE™ Total Ankle System. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove performance against specific acceptance criteria in the context of typical AI/medical device efficacy studies.
Here's an analysis of the provided information based on your requested points, highlighting that this is a device modification approval and not a de novo device efficacy study:
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Table of Acceptance Criteria and the Reported Device Performance:
Acceptance Criteria Reported Device Performance Criterion: Perform at least as well as the legally marketed predicate device. This is implicitly based on: - Material equivalence - Identical indications for use - Similar design features (despite slight difference in overall length of new size) - Mechanical integrity (specifically fatigue life) Performance: - The modified device utilizes the same materials as the predicate. - The indications for use are identical to the predicate device. - The design features are similar; the modification is the addition of a new size, differing only in overall length from existing sizes. - Fatigue testing was performed. The results show that the additional size "can be expected to perform at least as well as the legally marketed predicate." This is the key "performance" reported to meet the substantial equivalence claim. - Conclusion: "the subject devices can be expected to perform at least as well as the predicate devices." -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. This approval is based on a fatigue test for a mechanical device, not a performance study on a "test set" of patients or data in the context of AI/diagnostic devices. The sample size would refer to the number of devices or components tested in the fatigue assessment. This specific number is not provided in a way that relates to clinical "test sets."
- Data Provenance: Not applicable in the traditional sense of patient data. The data originates from mechanical fatigue testing performed on the device or its components. The location of testing is not specified, nor is whether it was prospective (new tests for this submission) or retrospective (re-analysis of previous test data, though unlikely for a new size).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. There is no "ground truth" derived from expert consensus on a test set of clinical cases. The "ground truth" for mechanical testing is typically defined by engineering specifications and standards for device breakage or wear, with evaluation performed by engineers or testing laboratories.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for clinical or diagnostic studies requiring expert review, which is not the nature of this submission.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting data. It's a mechanical implant. The document explicitly states "B.2. Substantial Equivalence - Clinical Evidence N/A".
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical orthopedic implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- As this is a mechanical device, the "ground truth" for its performance is established by engineering standards and specifications for mechanical integrity and fatigue life, demonstrated through fatigue testing. The comparison is to a predicate device's established performance under similar testing conditions.
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The sample size for the training set:
- Not applicable. This is not an AI or machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
Summary of the K103374 Submission:
This 510(k) submission is for a device modification (addition of a new size) to an existing orthopedic implant (INBONE™ Total Ankle System). The primary method used to demonstrate substantial equivalence, rather than meeting specific performance criteria against a clinical "ground truth," was:
- Comparison of Technological Characteristics: Showing identical indications, similar design features (with minor modification for size), and use of the same materials.
- Non-Clinical Evidence: Specifically, fatigue testing of the new size. The acceptance criterion was that the new size performs "at least as well as the legally marketed predicate" in terms of mechanical fatigue. The study essentially involved a direct comparison to the predicate's known or expected fatigue performance, implied to be successful if it met industry standards for such devices.
- Absence of Clinical Evidence: The submission explicitly states "N/A" for clinical evidence, indicating that no new human clinical trials were conducted or deemed necessary for this specific device modification.
Therefore, the "study" proving the device meets the (implied) acceptance criteria is the fatigue testing that demonstrated equivalent mechanical performance to the predicate device.
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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 RdArlington, TN 38002 |
|---|---|
| Date: | November 16, 2010 |
| Contact Person: | Kelsey LeeRegulatory 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 prosthesis87 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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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
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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
§ 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.