(181 days)
Not Found
No
The device description and intended use are for a physical implant (PEEK Knotless Anchors) used in surgical procedures. There is no mention of software, image processing, or any terms related to AI/ML.
Yes
This device is a therapeutic device because its intended use is to reattach soft tissue in various body parts, which is a treatment for injuries or conditions.
No
The device is a PEEK Knotless Anchor, used for soft tissue reattachment procedures. Its function is to secure tissue, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states the device is comprised of PEEK-Optima® polymer and is a physical soft tissue anchor, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the PEEK Knotless Anchors are used for soft tissue reattachment procedures in various anatomical locations. They are implanted devices used during surgery.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information about a patient's condition.
The device is a surgical implant used for repair and reconstruction, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair
Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction
Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair
Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement
The PEEK Knotless Anchors are single-use devices.
Product codes
HWC
Device Description
The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Wrist/Hand, Ankle/Foot, Elbow, Knee
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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 shows the word "BIOMET" in a stylized, blocky font. Above the word, there is a sequence of numbers and letters: K070389. The letters and numbers are handwritten and appear to be part of a code or identifier. The word "BIOMET" is the most prominent feature of the image.
P. 1/2
510(k) Summary
AUG - 9 2007
| Preparation Date: | February 8, 2007 |
|---|---|
| Applicant/Sponsor: | Biomet Sports Medicine, Inc. (formerly known as Arthrotek, Inc.) |
| Contact Person: | Susan Alexander |
| Proprietary Name: | PEEK Knotless Anchors |
| Common Name: | Soft tissue anchor |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21 CFR §888.3040), HWC |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| • ALLthread™ PEEK Suture Anchors | K060693 | Arthrotek, Inc. |
|---|---|---|
| • Resorbable Interference Screw | K041274 | Arthrotek, Inc. |
| • Soft Tissue Screw and Washer | K012572 | Arthrotek, Inc. |
Device Description: The PEEK Knotless Anchors are soft tissue anchors available in four diameters and comprised of PEEK-Optima® polymer.
Indications for Use:
Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair
Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valgus Reconstruction; and Mid and Forefoot Reconstruction
Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair
Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement
The PEEK Knotless Anchors are single-use devices.
Summary of Technologies: The technological characteristics (material, design, sizing, indications) of the PEEK Knotless Anchors are similar or identical to the predicate devices.
5-1 MAHING ADDRESS SHIPPING ADDRESS 1:0. Box 587 56 F. Bell Drive Warsaw, IN 46581 0587 Warsaw, IN 46582 ()FFICIE PAN E-MAII. 574.267.66.39 574.367.8147 biomet@blomet.com
1
070389
p. 2/2
510(k) Summary 510(k) Notification: PEEK Knotless Anchors Biomet Sports Medicine, Inc.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
All trademarks are property of Biomet, Inc. unless otherwise noted. PEEK-OPTIMA® is a registered trademark of Invibio, Inc.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, which is the department's symbol. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Sports Medicine, Inc. % Ms. Susan Alexander Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587
AUG = 9 2007
Re: K070389
Trade/Device Name: PEEK Knotless Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 4, 2007 Received: June 5, 2007
Dear Ms. Alexander:
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. Iisting 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 such 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); 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.
3
Page 2 -- Ms. Susan Alexander
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or at Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Babare Buchem
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: PEEK Knotless Anchors
Indications For Use:
Indications for the PEEK Knotless Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:
Shoulder: Bankart Repair; SLAP Repair; Acromio-clavicular Separation; Rotator Cuff Repair; Capsule Repair or Capsulolabral Reconstruction; Biceps Tenodesis; and Deltoid Repair
Wrist/Hand: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction
Ankle/Foot: Lateral Stabilization; Medial Stabilization; Achilles Tendon Repair/Reconstruction; Hallux Valqus Reconstruction; and Mid and Forefoot Reconstruction
Elbow: Ulnar or Radial Collateral Ligament Reconstruction; Biceps Tendon Reconstruction; and Lateral Epicondylitis Repair
Knee: Extra-capsular Repair; Medial Collateral Ligament Repair; Lateral Collateral Ligament Repair; Posterior Oblique Ligament Repair; Joint Capsule Closure; Iliotibial Band Tenodesis; Patellar Realignment and Repair; Patellar Ligament/Tendon Repair; and Vastus Medialis Obliquus (VMO) Muscle Advancement
The PEEK Knotless Anchors are single-use devices.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Senbere Budu
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ 4 - 1 R070389