(120 days)
The Smith & Nephew FOOTPRINT Ultra PK suture anchor family is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Hip: Distal row abductor tendon repair.
The FOOTPRINT Ultra PK is a suture anchor manufactured from polyetheretherketone. The tap-in anchor incorporates an anchor and plug and is pre-assembled on an inserter. The anchor accommodates up to four strands of suture and is offered diameters of 4.5 mm and 5.5 mm.
This document K113274 describes an indication expansion for the FOOTPRINT Ultra PK suture anchor. The main point of the submission is to justify the substantial equivalence of the device for "distal row abductor tendon repair" in the hip.
Here's an analysis of the provided information, specifically focusing on acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific quantitative acceptance criteria (e.g., a minimum pull-out strength in Newtons) nor does it provide detailed quantitative reported device performance data. Instead, it relies on a qualitative statement of "substantial equivalence" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantially equivalent static loading properties to predicates | "static loading properties that are substantially equivalent" |
| Substantially equivalent dynamic loading properties to predicates | "dynamic loading properties that are substantially equivalent" |
| No new safety or efficacy issues for distal row abductor tendon repair due to differences from predicates | "Testing also demonstrates that the differences in the FOOTPRINT Ultra PK suture anchor and the predicate does not raise any issues of safety and efficacy for distal row abductor tendon repair." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the performance testing. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided. The study performed is a mechanical/physical performance test of a medical device, not a diagnostic or interpretation study requiring expert ground truth for a dataset.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As mentioned above, the study is a mechanical performance test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance to assess the AI's impact on diagnostic accuracy. This submission is for a suture anchor, which is a physical implant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The FOOTPRINT Ultra PK suture anchor is a physical medical device, not an algorithm, so a "standalone" algorithmic performance study is not relevant.
7. Type of Ground Truth Used
The "ground truth" for this type of performance testing would be the actual physical properties (e.g., load to failure, displacement under load) measured in a laboratory setting. This is against established engineering and biomedical testing standards, not medical "ground truth" like pathology or outcomes data.
8. Sample Size for the Training Set
Not applicable. The FOOTPRINT Ultra PK suture anchor is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
Summary of Device Performance Study Details:
The submission indicates that the basis for the indication expansion is performance testing focused on the mechanical properties of the suture anchor.
- Type of Study: Mechanical/physical performance testing (static and dynamic loading).
- Objective: To demonstrate "substantial equivalence" of the device's loading properties to predicate devices, and that any differences do not raise safety or efficacy concerns for the new indication (distal row abductor tendon repair).
- Key Assertion: "Clinical literature has shown equivalence between repair techniques for shoulder rotator cuff and hip abductor tendon repair." This statement implies that if the device performs equivalently for existing indications, and if the repair techniques are equivalent, then the device should also be suitable for the new indication.
Missing Information:
Crucially, the provided text lacks specific quantitative data for the performance testing. Details such as:
- The exact parameters measured (e.g., ultimate tensile strength, pull-out force, cyclic loading cycles to failure).
- The specific test protocols or standards followed.
- The actual numerical results from the tests for both the subject device and the predicate devices.
- The statistical methods used to compare the performance.
Without these quantitative details, a comprehensive description of the acceptance criteria and the proven performance is limited to the qualitative statements provided in the 510(k) summary.
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K113274 (pg. 1 of 2)
MAR - 6 2012
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Indication Expansion - FOOTPRINT Ultra PK suture anchors
Date Prepared: November 4, 2011
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover MA, 01810
B. Company Contact
Melissa Egan, M.Sc. Regulatory Affairs Specialist II Phone: (508) 261-3645 FAX: (508) 261-3620
B. Device Name
| Trade Name: | FOOTPRINT Ultra PK suture anchor |
|---|---|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, fixation, nondegradable, soft tissue |
D. Predicate Devices
The indication of distal row abductor tendon repair is substantially equivalent to the currently marketed indications for use of the following legally marketed device in commercial distribution: The Smith & Nephew FOOTPRINT Ultra PK suture anchor (K093897) and the Arthrex Corkscrew suture anchor (K061665).
Description of Device E.
Ultra PK is a suture anchor manufactured from The FOOTPRINT The tap-in anchor incorporates an anchor and plug and is polyetheretherketone.
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K113274 (pg. 2 of 2)
pre-assembled on an inserter. The anchor accommodates up to four strands of suture and is offered diameters of 4.5 mm and 5.5 mm.
Intended Use F.
The intended use of the currently available suture anchors remains unchanged. The suture anchors are intended for fixation of soft tissues to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair. Knee: Medial collateral ligament repair, Lateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament
reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Hip: Distal row abductor tendon repair
G. Comparison of Technological Characteristics
Since there are no changes to the design the technological characteristics remain the same.
H. Summary Performance Data
Clinical literature has shown equivalence between repair techniques for shoulder rotator cuff and hip abductor tendon repair. The performance testing conducted includes static and dynamic loading properties that are substantially equivalent to the indicated predicates. Testing also demonstrates that the differences in the FOOTPRINT Ultra PK suture anchor and the predicate does not raise any issues of safety and efficacy for distal row abductor tendon repair.
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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Incorporated, Endoscopy Division % Melissa Egan, M.Sc. Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
MAR - 6 2012
Re: K113274
Trade/Device Name: FOOTPRINT Ultra PK suture anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation-fastener Regulatory Class: Class II Product Code: MBI Dated: February 29, 2012 Received: March 1, 2012
Dear Ms. Egan:
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.
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 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.
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Page 2 - Melissa Egan, M.Sc.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/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/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 r ou may 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.
cesfor You/industry/default.htm.
Sincerely yours,
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
KJ13274 510(k) Number (if known):
Device Name: FOOTPRINT Ultra PK suture anchor
Indications for Use:
The Smith & Nephew FOOTPRINT Ultra PK suture anchor family is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Hip: Distal row abductor tendon repair.
Prescription Use X (Per 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Livision Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113274
§ 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.