(23 days)
Not Found
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device description and intended use indicate it is an anchor system for reattaching soft tissue to bone, which is a surgical fixation device, not a therapeutic device designed to treat a disease or condition itself.
No
The device is a suture anchor used for the reattachment of soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "sterile single use anchor system which is designed to anchor suture to bone," indicating a physical, hardware-based medical device.
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 implant (suture anchor) used to attach soft tissue to bone within the body. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description confirms it's a sterile, single-use anchor system for anchoring suture to bone. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting markers, or providing information for diagnosis.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) and serves a structural/repair function.
N/A
Intended Use / Indications for Use
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle: Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand: Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment. Knee: Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
Product codes
HWC
Device Description
The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot, ankle, elbow, knee, wrist and hand
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)
Not Found
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
K02302/
SECTION V
OCT 0 4 2002
510(k) Summary
Smith & Nephew TwinFix Ti Quick T
Date Prepared: September 6, 2002
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 508.261.3658
B. Company Contact
William McCallum Regulatory Specialist
C. Device Name
| Trade Name: | Smith & Nephew TwinFix Ti Quick T |
|---|---|
| Common Name: | Suture Anchor |
| Suture, Nonabsorbable, Polyester | |
| Classification Name: | Screw, Fixation, Bone (HWC) |
D. Predicate Device
Smith & Nephew TwinFix Ti Quick T, K020159
E. Description of Device
The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissue.
1
Page 2 of 2
F. Intended Use
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle:
Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon
repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment.
Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
G. Comparison of Technological Characteristics
The Smith & Nephew TwinFix Ti Quick T is substantially equivalent in design, function, and intended use to the following predicate device:
Smith & Nephew TwinFix Ti Quick T, K020159, March 26, 2002
i'll be there
William McCallum Regulatory Specialist
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized lines forming the body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
OCT 04 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William McCallum Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 130 Forbes Blvd. Mansfield, MA 02048
Re: K023021
Trade/Device Name: TwinFix™ Ti Quick-T Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 10, 2002 Received: September 11, 2002
Dear Mr. McCallum:
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 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 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.
3
Page 2 - Mr. William McCallum
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 vours.
Mark A. Millman
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
510(k) Number:
Device Name: Smith & Nephew TwinFix Ti Quick T
Indications for Use :
· The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include:
Shoulder:
Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle:
Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions.
Elbow, Wrist and Hand:
Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, temnis elbow repair, and biceps tendon reattachment.
Knee:
Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (DE) Mark N Mille
(Division Sign-Off
Division of Gener Restorative
Neurological Devices
| Labels | Values |
|---|---|
| 510(k) Number | |
| Over-the-Counter | No |
Prescription Use (Per 21 CFR 801.109) OR
(Optional Format 1-2-96)