(246 days)
Not Found
No
The summary describes a physical suture anchor device and its intended use, material composition, and performance studies. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
Yes.
The device is a fixation device intended to provide secure attachment of soft tissue to bone until healing occurs, used for reattaching soft tissue to bone for various indications across multiple anatomical sites, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as a fixation device intended for the reattachment of soft tissue to bone, not for diagnosis.
No
The device description clearly states it is a physical fixation device consisting of a resorbable composite suture anchor with attached non-absorbable suture(s) preloaded onto an insertion device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "reattachment of soft tissue to bone" for various anatomical sites. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "fixation device" consisting of a suture anchor and suture, designed to be implanted into bone. This is a medical device used for structural support and repair within the body.
- 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 about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases, monitor health, or guide treatment decisions. This device is a surgical implant used for mechanical repair.
N/A
Intended Use / Indications for Use
The Smith & Nephew Osteoraptor OS Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament. reconstructions
Lateral epicondylitis repair
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Bunionectomy
Hip
Hip capsule repair
– Acetabular labrum reattachment
Knee
Extra-capsular repairs:
– Medial collateral ligament
– Lateral collateral ligament
– Posterior oblique ligament
Patellar realignment and tendon repairs
– Vastus medialis obliquous advancement
Iliotibial band tenodesis
Shoulder
Capsular stabilization
– Bankart repair
– Anterior shoulder instability
– SLAP lesion repairs
– Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
Product codes (comma separated list FDA assigned to the subject device)
MAI
Device Description
The Smith & Nephew OSTEORAPTOR OS Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone until healing occurs. The device consists of a resorbable composite suture anchor with attached non-absorbable suture(s) preloaded onto an insertion device. A 24 month ovine bone implantation study demonstrated that 9x10 mm implants typically resorb in approximately two years and are replaced by bone. This device is provided sterile, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Elbow, Wrist, Hand, Foot, Ankle, Hip, Knee, Shoulder
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)
Results of biocompatibility studies, animal studies, and in vitro testing demonstrate that Osteoraptor OS Anchors are substantially equivalent to predicate devices and the proposed modification to the anchor material does not raise new questions of safety and efficacy for these devices.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JAN 2 7 2011
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.
OSTEORAPTOR™ OS Suture Anchor
Date Prepared: 10 November 2010
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Julie Acker, RAC Senior Regulatory Affairs Specialist Phone: (508) 261-3618 Fax: (508) 261-3620
C. Device Name
| Trade Name: | OSTEORAPTOR OS Suture Anchor |
|---|---|
| Common Name: | Suture Anchor |
| Classification Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Product Code: | MAI |
| Regulation Number: | 21 CFR § 888.3030 |
D. Predicate Devices
The Smith & Nephew Osteoraptor OS Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Smith & Nephew OSTEORAPTOR Suture Anchors (K082215) and DePuy Mitek LUPINE BR Anchor (K070925).
E. Description of Device
The Smith & Nephew OSTEORAPTOR OS Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone until healing occurs. The device consists of a resorbable composite suture anchor with attached non-absorbable suture(s) preloaded onto an insertion device. A 24 month ovine bone implantation study demonstrated that 9x10 mm
1
implants typically resorb in approximately two years and are replaced by bone. This device is provided sterile, for single use only.
Intended Use
The Smith & Nephew Osteoraptor OS Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
| Elbow, Wrist, and Hand | Knee |
|---|---|
| Biceps tendon reattachment | Extra-capsular repairs: |
| Ulnar or radial collateral ligament. | |
| reconstructions | – Medial collateral ligament |
| Lateral epicondylitis repair | – Lateral collateral ligament |
| – Posterior oblique ligament | |
| Foot and Ankle | Patellar realignment and tendon repairs |
| Hallux valgus repairs | – Vastus medialis obliquous advancement |
| Medial or lateral instability | |
| repairs/reconstructions | Iliotibial band tenodesis |
| Achilles tendon repairs/reconstructions | |
| Midfoot reconstructions | Shoulder |
| Metatarsal ligament/tendon | |
| repairs/reconstructions | Capsular stabilization |
| Bunionectomy | – Bankart repair |
| – Anterior shoulder instability | |
| Hip | – SLAP lesion repairs |
| Hip capsule repair | – Capsular shift or capsulolabral |
| reconstructions | |
| – Acetabular labrum reattachment | Acromioclavicular separation repairs |
| Deltoid repairs | |
| Rotator cuff tear repairs |
F. Comparison of Technological Characteristics
The intended use; operating principle and design features of the Osteoraptor OS Suture Anchors are substantially equivalent to the legally marketed predicate anchors. Osteoraptor OS anchors are identical in design and intended use to the predicate Osteoraptor anchors except for the anchor material.
Biceps tenodesis
G. Summary Performance Data
Results of biocompatibility studies, animal studies, and in vitro testing demonstrate that Osteoraptor OS Anchors are substantially equivalent to predicate devices and the proposed modification to the anchor material does not raise new questions of safety and efficacy for these devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH &" is vertically oriented on the left side of the logo, and the text "HUMAN SERVICES" is vertically oriented on the right side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 7 2011
Smith & Nephew, Inc. Endoscopy Division % Julie Acker Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, MA 01810
Re: K101459
Trade/Device Name: OSTEORAPTOR OS Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: January 26, 2011 Received: January 27, 2011
Dear Ms. Acker:
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.
3
Page - 2 – Ms. Julie Acker
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 (2) 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/CDRHOPffices/ucm11178001/jpn1 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" (2116FR Preat 807.97). For questions regarding the reporting of adverse events under the MDR regulting (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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ay B. Rh
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Osteoraptor II Suture Anchors
The Smith & Nephew Osteoraptor II Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
KIO1459
Knee Elbow, Wrist, and Hand Biceps tendon reattachment Extra-capsular repairs: - Medial collateral ligament Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair - Lateral collateral ligament - Posterior oblique ligament Foot and Ankle Patellar realignment and tendon repairs Hallux valgus repairs - Vastus medialis obliquous advancement Medial or lateral instability repairs/reconstructions Iliotibial band tenodesis Achilles tendon repairs/reconstructions Shoulder Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Capsular stabilization Bunionectomy - Bankart repair - Anterior shoulder instability Hip - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions Hip capsule repair Acromioclavicular separation repairs - Acetabular labrum reattachment Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Prescription Use X
AND/OR
Over-The-Counter Use _
(Per 21 CFR 801 Subpart D)
(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)
Ar.M.Mulkerson
(Divisiøn Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K10/459
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