(129 days)
Not Found
No
The device description and intended use focus on a physical implant (allograft anchor) and its surgical application, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an allograft anchor kit used for the fixation of soft tissue to bone, which is a structural or mechanical support function, not directly therapeutic in itself.
No
The device is described as an "Allograft Anchor Kit" intended for "fixation of soft tissue to bone." Its function is to reattach soft tissue, which is a therapeutic or reconstructive purpose, not diagnostic.
No
The device description clearly states the device is composed of "machined cortical bone" and includes physical components like a threaded anchor, eyelets, suture, and a disposable driver. This indicates it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states that the Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is a device used for the fixation of soft tissue to bone during surgical procedures. It is implanted within the body to physically attach tissues.
The device's function is entirely mechanical and surgical, not diagnostic. It does not perform any tests on biological samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications:
Shoulder:
- Bankart lesion repairs
- SLAP lesion repairs
- Acromioclavicular separation repairs
- Rotator cuff tear repairs
- Capsular shift or capsulolabral reconstructions
- Biceps tenodesis
- Deltoid repairs
Foot and Ankle:
- Hallux valgus repairs
- Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
- Midfoot reconstructions
- Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
- Scapholunate ligament reconstructions
- Ulnar or radial collateral ligament reconstructions
- Lateral epicondylitis repair
- Biceps tendon reattachment
Knee:
- Extra-capsular repairs;
a. medial collateral ligament
b. lateral collateral ligament
c. posterior oblique ligament - Iliotibial band tenodesis
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
Product codes (comma separated list FDA assigned to the subject device)
MAI, JDW, BAS
Device Description
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit composed of machined cortical bone. The anchor is of a threaded design with two (2) evelets, to which braided #2 USP suture is attached (one per eyelet). The proximal end of the anchor accepts a disposable driver, which is used as the insertion device. The anchor requires a tapping procedure prior to implantation. Following the implantation of the anchor, the free ends of the suture are used to reattach soft tissue to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Wrist, and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing has been performed to support substantial equivalance.
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
011985 p 1/2
NOV 0 2 2001
510(k) Summary Smith & Nephew Phoenix 5.0 Allograft Anchor Kit Revision Date: September 24, 2001
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
A. Submitter
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810
B. Company Contact
Tim Crabtree Regulatory Affairs Specialist
C. Device Name
Trade Name: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit Common Name; Soft Tissue Suture Anchor Classification Name: Unclassified
D. Predicate Devices
Smith & Nephew Preloaded PRC5 5.0 mm Polyacetal Suture Anchor (K982963) Multitak SS Bone Anchor (K993115)
E. Description of Device
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit composed of machined cortical bone. The anchor is of a threaded design with two (2) evelets, to which braided #2 USP suture is attached (one per eyelet). The proximal end of the anchor accepts a disposable driver, which is used as the insertion device. The anchor requires a tapping procedure prior to implantation. Following the implantation of the anchor, the free ends of the suture are used to reattach soft tissue to bone.
F. Intended Use
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications:
Shoulder:
-
- Bankart lesion repairs
-
- SLAP lesion repairs
1
K011985 p²/2
-
- Acromioclavicular separation repairs
-
- Rotator cuff tear repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux valgus repairs
-
- Medial or lateral instability repairs/reconstructions
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- Lateral epicondylitis repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular repairs;
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
-
- Iliotibial band tenodesis
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
G. Comparison of Technological Characteristics
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is substantially equivalent in design, function and intended use to the Smith & Nephew PRC5 Polyacetal Anchor. Performance testing has been performed to support substantial equivalance. It is substantially equivalent in its materials and use to the Mutlitak SS Bone Anchor.
Tm Cobb
Tim Crabtree Regulatory Affairs Specialist
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, symbolizing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 2 2001
Mr. Tim Crabtree Regulatory Affairs Specialist Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810
Re: K011985
Trade/Device Name: Smith & Nephew Phoenix 5.0 Allograft Anchor Kit Regulation Number: 21 CFR 888.3040 and 878.5000 Regulation Name: Smooth or threaded metallic bone fixation fastener and nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: Class II Product Code: MAI, JDW, BAS Dated: June 19, 2001 Received: June 26, 2001
Dear Mr. Crabtree:
We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal the encreaters of to 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 r ou may , ateres, mains of the Act include requirements for annual registration, listing of general controls proficious 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 If your device is elassince (soo as 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 r reaso or action and intermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must corply 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 orth 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.
3
Page 2 - Mr. Tim Crabtree
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
for Marli N-Mellman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NOV 0 2 2001 510(k) Number :
Device Name : The Smith & Nephew Phoenix 5.0 Allograft Kit
Indications for Use :
The Smith & Nephew Phoenix 5.0 Allograft Anchor Kit is intended for use only for the fixation of soft tissue to bone for the following indications:
Shoulder:
-
- Bankart lesion repairs
-
- SLAP lesion repairs
-
- Acromioclavicular separation repairs
-
- Rotator cuff tear repairs
-
- Capsular shift or capsulolabral reconstructions
-
- Biceps tenodesis
-
- Deltoid repairs
Foot and Ankle:
-
- Hallux valgus repairs
-
- Medial or lateral instability repairs/reconstructions
-
- Achilles tendon repairs/reconstructions
-
- Midfoot reconstructions
-
- Metatarsal ligament/tendon repairs/reconstructions
Elbow, Wrist, and Hand:
-
- Scapholunate ligament reconstructions
-
- Ulnar or radial collateral ligament reconstructions
-
- Lateral epicondylitis repair
-
- Biceps tendon reattachment
Knee:
-
- Extra-capsular repairs:
- a. medial collateral ligament
- b. lateral collateral ligament
- c. posterior oblique ligament
-
- Iliotibial band tenodesis
-
- Patellar realignment and tendon repairs, including vastus medialis obliquous advancement
fo Mark N Milliman
storative 011985
510(k) Number
Smith & Nephew Phoenix5.0 Allograft Anchor Kit Page 19 of 64