(89 days)
Not Found
No
The summary describes a mechanical suture anchor and its intended uses, with no mention of AI or ML technology.
Yes
The device is intended for the reattachment of soft tissue to bone for various orthopedic indications, which aligns with the definition of a therapeutic device.
No
The device is a suture anchor used for reattaching soft tissue to bone, which is a therapeutic rather than diagnostic function. It does not analyze or interpret patient data for diagnosis.
No
The device description clearly states it is a suture anchor with attached suture(s) preassembled to an insertion device, indicating it is 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 clearly describes a surgical device for reattaching soft tissue to bone in various anatomical locations. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device is described as a suture anchor with attached sutures and an insertion device. This is consistent with a surgical implant and delivery system.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on insertion and fixation properties, which are relevant to the mechanical function of a surgical implant, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a surgical tool used within the body for repair.
N/A
Intended Use / Indications for Use
The Smith & Nephew OSTEORAPTOR Suture Anchor is 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, JDR, HWC
Device Description
The device consists of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. 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, Knee, Foot, Ankle, Hip, 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)
The performance testing conducted demonstrates that the insertion and fixation properties of the OSTEORAPTOR Anchor are substantially equivalent to the predicate 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
K082215-
P. 1/2
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
NOV - 3 2008
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® Suture Anchor
Date Prepared: 04 August 2008
- A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Julie Acker, RAC Regulatory Affairs Specialist
Phone: (508) 261-3618 FAX: (508) 261-3620
C. Device Name
| Trade Name: | OSTEORAPTOR 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 Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: BIORAPTOR 2.9 Anchor (K053344) and BIORAPTOR 2.3 PK Anchor (K071586).
E. Description of Device
The device consists of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. This device is provided sterile, for single use only,
. . . .
Smith & Nephew, Inc. Endoscopy Division
Page 10 of 61
OSTEORAPTOR 510(K)
1
F. Intended Use
The Smith & Nephew OSTEORAPTOR Suture Anchor is 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 | lliotibial 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 reconstruction |
| - Acetabular labrum reattachment | Acromioclavicular separation repairs |
| Deltoid repairs | |
| Rotator cuff tear repairs | |
| Biceps tenodesis |
G. Comparison of Technological Characteristics
The Smith & Nephew OSTEORAPTOR Suture Anchor is substantially equivalent to the predicate anchors. The proposed and predicate anchors are similar in design, operate on the same principles, have the same indications and intended use, and exhibit similar fixation properties.
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the OSTEORAPTOR Anchor are substantially equivalent to the predicate devices.
Smith & Nephew, Inc. Endoscopy Division
Page 11 of 61
OSTEORAPTOR 510(K)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is black in color. The eagle is also black and is made up of several curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 3 2008
Smith & Nephew, Inc. Endoscopy Division % Ms. Julie Acker 150 Minuteman Road Andover, Massachusetts 01810
Re: K082215
Trade/Device Name: Osteoraptor™ 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: JDR, HWC, MAI Dated: August 4, 2008 Received: August 6, 2008
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. 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
3
Page 2 - Ms. Julie Acker
1950 (1992) 1992 (1992) 1992 (1992) 1992 (1992) 1998 (1992) 1999 (1998) 1992 1992 1992 (1992) 1992 1992 (1992) 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 199
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.
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 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M Millman
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
Kop 2215
510(k) Number (if known):
Device Name: OSTEORAPTOR® Suture Anchor
The Smith & Nephew OSTEORAPTOR Suture Anchor is 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
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | /o |
|---|---|
| (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number