(79 days)
No
The document describes suture anchors and their intended uses, focusing on mechanical properties and expanding existing indications. There is no mention of AI or ML technology.
Yes: The device, Suture Anchors, is used for the reattachment of soft tissue to bone, which is a therapeutic intervention for various injuries and conditions across multiple anatomical sites.
No
The device description and intended use clearly state that these are suture anchors used for the reattachment of soft tissue to bone and reconstruction in various anatomical sites. This indicates a therapeutic or reconstructive purpose, not a diagnostic one.
No
The device description explicitly states that the subject of the 510(k) is an addition to the indications for use for existing suture anchors, which are physical medical devices. The submission is for expanding the use of hardware, not introducing a new software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the reattachment of soft tissue to bone for various anatomical sites and surgical procedures. This is a surgical device used in vivo (within the body) during a procedure.
- Device Description: The device is described as "Suture Anchors," which are implants used to secure sutures to bone. This is consistent with a surgical implant, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the Smith & Nephew Suture Anchors are surgical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors are intended for use in the attachment or reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum reattachment/reconstruction)
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
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis
Product codes
MAI, MBI
Device Description
Subject of this Traditional 510(k) premarket notification is an addition to the indications for use for the Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K082215, and K093428, respectively, and have identical indications for use. Smith & Nephew, Inc. seeks to expand the existing indications for use for the subject devices to include acetabular labrum reconstruction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Shoulder, Foot and Ankle, Elbow, Wrist, Hand, 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K053344, K071586, K082215, K093428
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
K121018(1/3)
JUN 2 2 2 2012
510(k) Summary Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® PK 2.3, OSTEORAPTOR®, and BIORAPTOR® Knotless Suture Anchors
| Submitted by: | Smith & Nephew, Inc.
150 Minuteman Road
Andover, MA 01810 |
| --------------- | ----------------------------------------------------------------- |
|---|
| Date of Summary: | April 3, 2012 |
|---|---|
| Contact Person and Address: | John Connor, Regulatory Affairs Specialist |
| T (901) 399-5944 F (901) 566-7961 | |
| Name of Device(s): | Smith & Nephew, Inc. BIORAPTOR® 2.9 Suture Anchor |
| Smith & Nephew, Inc. BIORAPTOR® 2.3 PK Suture | |
| Anchor | |
| Smith & Nephew, Inc OSTEORAPTOR® Suture Anchor | |
| Smith & Nephew, Inc. BIORAPTOR® Knotless Suture | |
| Anchor | |
| Common Name: | Fastener, Fixation, Biodegradable, Soft Tissue |
| Fastener, Fixation, Nondegradable, Soft Tissue | |
| Device Classification Name and | |
| Reference: | 21 CFR 888.3030 Single/multiple component metallic |
| bone fixation appliances and accessories |
21 CFR 888.3040 Smooth or threaded metallic bone
fixation fastener |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | MAI, MBI |
Device Description
Subject of this Traditional 510(k) premarket notification is an addition to the indications for use for the Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. These suture anchors were cleared via premarket notifications K053344, K071586, K082215, and K093428, respectively, and have identical indications for use. Smith & Nephew, Inc. seeks to expand the existing indications for use for the subject devices to include acetabular labrum reconstruction.
Technological Characteristics
There have been no major changes in design or materials in the subject suture anchors since their market clearance. As such, the technological characteristics of the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK OSTEORAPTOR®, and BIORAPTOR® Knotless Suture Anchors have not changed.
1
KI21018(
$$^{2}/_{3}$$
)
Intended Use
The Smith & Nephew, Inc. BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors are intended for use in the attachment or reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum reattachment/reconstruction)
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
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis
Substantial Equivalence Information
The substantial equivalence of the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors is based on similarities in indications for use, design features, operational principles, and material composition to the predicate devices listed in the table below. As there have been no significant changes to the design of the subject suture anchors, and the expansion of indications for use to include labral reconstruction introduces no additional risk, Smith & Nephew is relying on the mechanical testing (insertion strength, pull-out strength, and suture sliding) provided for the predicate devices as a measure of substantial equivalence.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------|------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | BIORAPTOR® 2.9 Suture Anchors | K053344 | 02/23/2006 |
| Smith & Nephew, Inc. | BIORAPTOR® 2.3 PK Suture Anchors | K071586 | 08/17/2007 |
| Smith & Nephew, Inc. | OSTEORAPTOR® Suture Anchors | K082215 | 11/03/2008 |
| Smith & Nephew, Inc. | BIORAPTOR® Knotless Suture Anchors | K093428 | 12/17/2009 |
2
2
KI21018(3/3)
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to expand the indications for use for the BIORAPTOR® 2.9, BIORAPTOR® 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors. Based on the similarities to the predicate components and published articles supporting the additional indication, the devices are substantially equivalent to their predicates.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and wings, and a wavy line representing its tail.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 2 2012
Smith and Nephew, Inc. % Mr. John Connor 7135 Goodlett Farms Parkway Cordova, Tennesee 38016
Re: K121018
Trade/Device Name: BIORAPTOR™ 2.9, BIORAPTOR™ 2.3 PK, OSTEORAPTOR™, and BIORAPTOR™ Knotless Suture Anchors
Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, MAI Dated: April 3, 2012 Received: April 4, 2012
Dear Mr. Connor:
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.
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
4
Page 2 - Mr. John Connor
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/ReportalProblem/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,
Eil Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Premarket Notification Indications for Use Statement
510(k) Number (if known): _ K121018
Device Name:
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR®, and BIORAPTOR Knotless Suture Anchors
Indications for Use:
The Smith & Nephew Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:
Hip
Hip capsule repair
- Acetabular labrum .
- reattachment/reconstruction
Shoulder
Capsular stabilization
- . Bankart repair
- Anterior shoulder instability .
- SLAP lesion repairs .
- Capsular shift or capsulolabral . reconstructions
Acromioclavicular separation repairs Deltoid repairs
Rotator Cuff repairs Biceps Tenodesis
Foot and Ankle
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy
Knee
.
Extra-capsular repairs
reconstructions
Elbow, Wrist, and Hand
Lateral epicondylitis repair
Biceps tendon reattachment
Ulnar or radial collateral ligament
- Medial collateral ligament .
- Lateral collateral ligament .
- Posterior oblique ligament .
Patellar realignment and tendon repairs
- Vastus medialis obliquous ● advancement
Iliotibial band tenodesis
Ast
(Division 'lign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
K121018 510(k) Number
AND/OR Prescription Use __ X (Part 21 CFR 801.109) l
Over-the-Counter Use _ (Optional Format 1-2-96)
(Please do not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)