(147 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a suture anchor, with no mention of AI or ML.
No.
A therapeutic device is typically understood as a device that delivers medicine, radiation, or other forms of treatment. This device, a suture anchor, is used for soft tissue to bone fixation, which assists in healing but does not directly provide therapy.
No
The device description indicates it is a suture anchor used for soft tissue to bone fixation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical suture anchor made of materials like Biocryl Rapide, Titanium, or Peek, preloaded on a disposable inserter assembly. This is a hardware device, not software.
Based on the provided information, the TransTend Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "soft tissue to bone fixation in association with post-operative immobilization" in various anatomical locations. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant (suture anchor) made of different materials, preloaded on an inserter, and used for fixing suture to bone. This is a medical device used in the body, not a reagent or instrument used to analyze biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the TransTend Anchor is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with postoperative immobilization as follows:
| Indication | BR | PEEK | Titanium | |
|---|---|---|---|---|
| Shoulder | Rotator Cuff | X | X | X |
| Partial Thickness Rotator Cuff | X | X | X | |
| Biceps Tenodesis | X | X | ||
| Acromio-Clavicular Separation | X | X | ||
| Deltoid Repair | X | X | ||
| Foot/Ankle | Lateral Stabilization | X | X | |
| Medial Stabilization | X | X | ||
| Mid-foot Reconstruction | X | X | ||
| Hallux Valgus Repair | X | X | ||
| Metatarsal Ligament/Tendon Repairs | X | X | ||
| Knee | Medial Collateral Ligament Repair | X | X | |
| Lateral Collateral Ligament Repair | X | X | ||
| Posterior Oblique Ligament Repair | X | X | ||
| Iliotibial Band Tenodesis | X | X | ||
| Elbow | Lateral Epicondylitis Repair | X | X | |
| Wrist | Scapholunate Ligament Reconstruction | X | X | |
| Hip | Capsular Repair | X | X | |
| Acetabular Labral Repair | X | X |
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI, MAI
Device Description
The proposed TransTend Anchors are suture anchors offered in three different materials, namely Biocryl Rapide, Titanium or Peek. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The TransTend Anchors are provided as size 3.4 mm in Biocryl Rapide, 3.4mm in Peek and 2.9 mm in Titanium. Each TransTend Anchor is provided sterile and is for single patient use only. The TranTend anchors will also be offered in a convenience kit and be packaged with a cannula assembly along with one or two TransTend Anchor(s).
Technologies characteristics including material for design, and packaging are the same as the predicates cleared devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Elbow, Wrist, Hip
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)
Verification activities were performed on the implant or its predicates. Testing includes pull out testing, insertion torque testing, sterilization and biocompatibility.
Results of performance and safety testing have demonstrated that the proposed devices are suitable for their intended use.
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed TransTend Anchors Anchor (s) have shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
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.
K100012, K090124, K073412, K082282, K071481, K082810, K081598, K020159
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
§ 888.3040 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.
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510(k) SUMMARY
TransTend Anchors
JAN - 7 2011
| Submitter's Name
and Address: | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo
Regulatory Affairs Project Manager
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3359
Facsimile: 508-977-6955
e-mail: KChristo@its.jnj.com
Prepared 10/30/2010 |
| Name of Medical
Device | Classification Name: Single/multiple component metallic bone fixation
appliances and accessories |
| | Common/Usual Name: Bone Anchor |
| | Proprietary Name: TransTend Anchors |
| Substantial
Equivalence | The proposed TransTend Anchors are substantially equivalent to:
K100012 Gryphon Br - Hip (March 10, 2010) K090124 Gryphon P BR Anchor (March 11, 2009) K073412 Gryphon BR / Healix BR Anchors (January 17, 2008) K082282 Healix Ti Anchor (November 7, 2008) K071481 Healix Peek Anchor (August 9, 2007) K082810 Arthrex BioComposite Corkscrew Anchor (January 23, 2009) K081598 KFX Suture lock Nail Bone Anchor (July 3, 2008) K020159 Twin Fix Ti Quick T 3.5 mm Fixation System ( March 26, 2010) |
| Device
Classification | These devices carry an FDA product code HWC, and subsequent codes MBI and
MAI, regulated under 21 CFR 888.3040 and 21 CFR 888.3030. |
| | The proposed TransTend Anchors are suture anchors offered in three different |
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p. 2012
Device Description
materials, namely Biocryl Rapide, Titanium or Peek. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The TransTend Anchors are provided as size 3.4 mm in Biocryl Rapide, 3.4mm in Peek and 2.9 mm in Titanium. Each TransTend Anchor is provided sterile and is for single patient use only. The TranTend anchors will also be offered in a convenience kit and be packaged with a cannula assembly along with one or two TransTend Anchor(s).
Technologies characteristics including material for design, and packaging are the same as the predicates cleared devices.
The TransTend Anchor is indicated for use in soft tissue to bone fixation in Indications for association with post-operative immobilization as follows: Use
| Indication | BR | PEEK | Titanium | |
|---|---|---|---|---|
| Shoulder | Rotator Cuff | X | X | X |
| Partial Thickness Rotator Cuff | X | X | X | |
| Biceps Tenodesis | X | X | ||
| Acromio-Clavicular Separation | X | X | ||
| Deltoid Repair | X | X | ||
| Foot/Ankle | Lateral Stabilization | X | X | |
| Medial Stabilization | X | X | ||
| Mid-foot Reconstruction | X | X | ||
| Hallux Valgus Repair | X | X | ||
| Metatarsal Ligament/Tendon Repairs | X | X | ||
| Knee | Medial Collateral Ligament Repair | X | X | |
| Lateral Collateral Ligament Repair | X | X | ||
| Posterior Oblique Ligament Repair | X | X | ||
| Iliotibial Band Tenodesis | X | X | ||
| Elbow | Lateral Epicondylitis Repair | X | X | |
| Wrist | Scapholunate Ligament Reconstruction | X | X | |
| Hip | Capsular Repair | X | X | |
| Acetabular Labral Repair | X | X |
Non clinical Testing
Verification activities were performed on the implant or its predicates. Testing includes pull out testing, insertion torque testing, sterilization and biocompatibility.
Results of performance and safety testing have demonstrated that the proposed Safety and devices are suitable for their intended use. Performance
Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed TransTend Anchors Anchor (s) have shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek, Inc. % Ms. Kristine Christo Regulatory Affairs Project Manager 325 Paramount Drive Raynham, Massachusetts 02767
JAN - 7 2011
Re: K102298
Trade/Device Name: TransTend (BR, Ti, Peek) Anchors Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, MAI Dated: December 30, 2010 Received: January 03, 2011
Dear Ms. Christo:
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.
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
3
Page 2 - Ms. Kristine Christo
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 (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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
For Peter Dunn
Mark N. Melkerson Director Division of Surgical. Orthonedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K102298
JAN - 7 2011
· Device Name: TransTend (BR, Ti, Peek) Anchors
The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with postoperative immobilization as follows:
| Indication | BR | PEEK | Titanium | |
|---|---|---|---|---|
| Shoulder | Rotator Cuff | X | X | X |
| Partial Thickness Rotator Cuff | X | X | X | |
| Biceps Tenodesis | X | X | ||
| Acromio-Clavicular Separation | X | X | ||
| Deltoid Repair | X | X | ||
| Foot/Ankle | Lateral Stabilization | X | X | |
| Medial Stabilization | X | X | ||
| Mid-foot Reconstruction | X | X | ||
| Hallux Valgus Repair | X | X | ||
| Metatarsal Ligament/Tendon Repairs | X | X | ||
| Knee | Medial Collateral Ligament Repair | X | X | |
| Lateral Collateral Ligament Repair | X | X | ||
| Posterior Oblique Ligament Repair | X | X | ||
| Iliotibial Band Tenodesis | X | X | ||
| Elbow | Lateral Epicondylitis Repair | X | X | |
| Wrist | Scapholunate Ligament Reconstruction | X | X | |
| Hip | Capsular Repair | X | X | |
| Acetabular Labral Repair | X | X |
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Page 1 of_1
for M.Mdkerrm
(Division Sign Off)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102298