(116 days)
Not Found
No
The summary describes a mechanical bone anchor system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a "bone anchor system" used for "fixation of soft tissue to bone" in various orthopedic procedures, which is a structural or mechanical function rather than a therapeutic one (i.e., treating a disease or condition directly).
No
The device is described as a "bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures" for "fixation of soft tissue to bone." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it is a "bone anchor system with inserter handle," indicating it includes physical hardware components.
Based on the provided information, the SpeedLock Knotless Fixation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of soft tissue to bone" in various anatomical locations. This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as a "bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures." This further reinforces its use in surgical interventions.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or repair structures within the body. The SpeedLock Knotless Fixation Device is a surgical implant used for mechanical fixation.
N/A
Intended Use / Indications for Use
The SpeedLock Knotless Fixation Device with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Product codes
MBI
Device Description
The SpeedLock Knotless Fixation Device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle, Foot, Elbow, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Side by side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors. The differences between the SpeedLock and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices.
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
K111044 #1/2
510(K) SUMMARY
AUG - 9 2011
ARTHROCARE CORPORATION SPEEDLOCK KNOTLESS FIXATION SYSTEM
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-3523
Establishment Registration No .:
Contact Person:
2951580 Laura N. Kasperowicz
Sr. Manager, Regulatory Affairs
Date Prepared:
April 14, 2011
Device Description
Model Name: Generic/Common Name: Classification Name: Device Classification:
Model Name: Generic/Common Name:
Model Name: Generic/Common Name:
Model Name: Generic/Common Name:
Model Name: Generic/Common Name:
Model Name: Generic/Common Name:
Predicate Devices Opus® SpeedLock® Knotless Fixation Device SpeedLock Knotless Fixation Device Bone Anchor, Fastener, Fixation, Soft Tissue Fastener, Fixation, Nondegradeable, Soft Tissue Class II per 21 CFR 888.3040, Product code: MBI
Drill, 3.0 mm Bone Drill
PathFinder® Obturator Bone Hole Locator
Sharp-Tipped Obturator Bone Hole Locator
Drill Guide, 3.5mm High Visibility Drill Guide
Drill Guide, 3.5mm Low Profile Drill Guide
K090615 (June 3, 2010)
Product Description
The SpeedLock Knotless Fixation Device is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
1
K111044 **
510(K) SUMMARY
Indications For Use
The SpeedLock Knotless Fixation Device with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Substantial Equivalence
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The SpeedLock Knotless Fixation device design and technology is substantially equivalent to the existing SpeedLock Knotless Fixation Device [K090615]. Side by side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors. The differences between the SpeedLock and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices.
Summary and Reason for 510k Notification
The purpose of this 510(k) is to notify the Food and Drug Administration of a proposed modification to an existing product. The proposed device, the SpeedLock Knotless Fixation Device is substantially equivalent to the SpeedLock Knotless Fixation Device originally cleared under K090615.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or feathers. The symbol is stylized and modern in appearance.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Arthrocare Corporation % Ms. Laura Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
AUG - 9 2011
Re: K111044
Trade/Device Name: Speedlock® Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 30, 2011 Received: July 05, 2011
Dear Ms. Kasperowicz:
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 warrantics. 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
3
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and Restorative Devices and Restoraice Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K 111044 |
|---|---|
| Device Name: | SpeedLock® Knotless Fixation System |
| Indications for Use: |
The SpeedLock Knotless Fixation Device is indicated for use in fixation of soft tissue to
bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator
cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair
Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and
midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior
oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular
reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR X
Over-The-Counter Use (21 CFR 801 Subpart C) NO
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KL 111/044
page v
510(k) Number