(121 days)
K 120943
Not Found
No
The document describes a mechanical bone anchor and inserter system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical properties and functional testing.
No
The device is a bone anchor used for fixation of soft tissue to bone, which is a structural or supportive function, not directly therapeutic (i.e., treating a disease or health problem).
No
The device is a surgical implant designed for fixation of soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly states it is a bone anchor with an inserter handle, made of PEEK, and includes associated instruments. This describes a physical medical 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 is "fixation of soft tissue to bone in the hip." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bone anchor with inserter handle" designed for use in "arthroscopic and orthopedic procedures." This describes a surgical implant and its delivery system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:
- Hip capsule repair
- Acetabular labrum reattachment
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of suture to tissue.
The SpeedLock HIP consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The SpeedLock HIP Knotless Fixation System also includes associated instruments for implanting the anchor into bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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 Data:
- Design Verification testing to demonstrate conformance with device specifications. This testing included functional testing of all aspects of device performance, use of the device with ancillary devices, and anchor deployment, bone lock and suture lock in a foam bone model.
- Insertion testing in a simulated hard bone substrate.
- Side-by-side comparative testing of the modified and predicate devices, including static and cyclic suture and anchor pull testing, as well as elements of standard verification testing.
Key results: The test results demonstrate that the modified SpeedLock HIP Knotless Fixation Implant meets its design, performance, and safety specifications and that it performs substantially equivalently to the predicate SpeedLock HIP Knotless Fixation Implant.
Clinical Data: No clinical or animal data are included in this submission.
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.
K 120943
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
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 logo for ArthroCare. The logo consists of a stylized, circular graphic on the left and the word "ArthroCare" on the right. The graphic is made up of several curved lines that create a sense of motion or rotation. The text "ArthroCare" is in a bold, sans-serif font, with a small trademark symbol next to the word.
510(k) Summary
ArthroCare® Corporation SpeedLock® HIP Knotless Fixation Implant FEB 1 4 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | ArthroCare Corporation |
|---|---|
| Address | 7000 West William Cannon Drive |
| Austin, TX 78735 | |
| Contact Person: | Cheryl Frederick |
| Director, Regulatory Affairs | |
| Phone: 512-391-5751 | |
| Fax: 512-895-1489 | |
| Date Prepared: | January 31, 2013 |
Device Name
| Proprietary Name: | SpeedLock® HIP Knotless Fixation Implant |
|---|---|
| Common Name: | Bone Anchor |
| Classification Name: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Device Class: | Class II |
| Product Code: | MBI |
| CFR Section: | 21 CFR 888.3040 |
Predicate Device
This 510(k) relates to a modification to the SpeedLock HIP Knotless Fixation Implant cleared under K 120943 (September 21, 2012).
Description
The SpeedLock HIP Knotless Fixation Implant (SpeedLock HIP) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures. With this anchor, surgical knots are not necessary for the fixation of suture to tissue.
The SpeedLock HIP consists of two primary parts: a 3.4 mm PEEK bone anchor and a disposable anchor inserter which is preloaded with the anchor. The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The SpeedLock HIP Knotless Fixation System also includes associated instruments for implanting the anchor into bone.
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K123240
The design modification that is the subject of this Premarket Notification relates to the internal detachment feature of the SpeedLock HIP anchor. The modification does not alter the overall device characteristics or the manner in which the device is used, and there are no changes to the device's cleared indications for use.
Intended Use/Indications For Use
The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:
- 0 Hip capsule repair
- Acetabular labrum reattachment
Non-Clinical Data
The following testing was submitted in support of a determination of substantial equivalence between the predicate and modified devices:
- Design Verification testing to demonstrate conformance with device specifications. This testing included functional testing of all aspects of device performance, use of the device with ancillary devices, and anchor deployment, bone lock and suture lock in a foam bone model.
- . Insertion testing in a simulated hard bone substrate.
- 트 Side-by-side comparative testing of the modified and predicate devices, including static and cyclic suture and anchor pull testing, as well as elements of standard verification testing.
The test results demonstrate that the modified SpeedLock HIP Knotless Fixation Implant meets its design, performance, and safety specifications and that it performs substantially equivalently to the predicate SpeedLock HIP Knotless Fixation Implant.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the modified SpeedLock HIP Knotless Fixation Implant performs as intended and has acceptable mechanical properties when used in accordance with its labeling.
Since the modified device's intended use and technological characteristics are the same as those for the previously cleared device, we do not believe that the modification to the SpeedLock HIP Knotless Fixation Implant raises any new questions of safety or effectiveness.
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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 features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure with its wings spread, suggesting protection and care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2013
ArthroCare Corporation % Ms. Cheryl Frederick Director, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735
Re: K123240
Trade/Device Name: SpeedLock® HIP Knotless Fixation Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 21, 2013 Received: January 22, 2013
Dear Ms. Frederick:
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
3
Page 2 - Ms. Cheryl Frederick
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.
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 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,
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K123240
Indications for Use
510(k) Number (if known): Not yet assigned
Device Name: SpeedLock® HIP Knotless Fixation Implant
Indications for Use:
The SpeedLock HIP Knotless Fixation Implant is indicated for use in fixation of soft tissue to bone in the hip. Examples of such procedures include:
- · · Hip capsule repair
- I Acetabular labrum reattachment
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD 2013.02.12 13:48:09 -05'00' Division of Orthopedic Devices
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