(88 days)
No
The document describes a mechanical suture anchor and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a "threaded suture anchor" intended for "fixation of #2 suture to bone" for various repairs (e.g., rotator cuff repair, ligament repair), indicating its direct involvement in the treatment and repair of bodily structures, which is a therapeutic function.
No
This device is a non-absorbable threaded suture anchor used for fixation of sutures to bone during surgical repairs, not for diagnosis.
No
The device description clearly states it is a "non-absorbable threaded suture anchor manufactured of Titanium material" and comes "preloaded on a disposable inserter assembly." This describes a physical hardware device, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "non-absorbable threaded suture anchor manufactured of Titanium material" intended for "fixation of #2 suture to bone" for various surgical repairs in the shoulder, foot/ankle, knee, elbow, and hip.
- Lack of Diagnostic Activity: The device's function is purely mechanical and surgical. It is used to physically attach tissue to bone during a surgical procedure. It does not analyze biological samples or provide diagnostic information.
Therefore, the Healix Ti Anchor is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Healix Ti Anchor is intended for:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella tendon repair and secondary fixation in ACL / PCL reconstruction repair.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hip: Capsular repair, acetabular labral repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC, JDR
Device Description
The Healix Ti Anchor is a non-absorbable threaded suture anchor manufactured of Titanium material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The anchor is provided in three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through The Healix Anchors are currently offered with absorbable tissue. Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Elbow, 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)
Results of performance and safety testing have demonstrated that the modified device is 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.
K071481, K060664, K0041075, K052631, K040004, K043298
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.
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.
0
Koby2 P. 1/2
SECTION 2 -- 510(k) SUMMARY
.
ﭘﺎﮐﺴﺘﺎﻥ ﮐﮯ ﺷﮩﺮ
| Healix Ti Anchor | NOV 07 2008 | |
|---|---|---|
| Submitter's Name and | ||
| Address: | DePuy Mitek | |
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Contact Person | Kristine Christo | |
| Regulatory Affairs Project Lead | ||
| DePuy Mitek | ||
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Telephone: | ||
| 508-828-3359 | ||
| Facsimile: | ||
| 508-828-3750 | ||
| e-mail: KChristo@Dpyus.jnj.com | ||
| Name of Medical Device | Classification Name: | Fastener, Fixation, Nondegradable, Soft |
| Tissue Smooth or threaded metallic bone | ||
| fixation fasteners | ||
| Common/Usual Name: | Bone Anchor | |
| Proprietary Name: | Healix Ti Anchor | |
| Substantial Equivalence | Healix Ti Anchor is substantially equivalent to: | |
| Mitek Healix Anchor K071481(Aug 9, 2007) | ||
| Fastin RC Anchor K060664,K0041075 (June 6, 2006; Nov 9, 2004). | ||
| Super QA+ Anchor K052631 (Oct 21, 2005) | ||
| Orthocord, violet (size #2) suture, K040004 (April 13, 2004) | ||
| Orthocord blue (size #2) suture, K043298 (Dec 10, 2004). | ||
| The Healix Ti Anchor is also similar to the Arthrex Corkscrew FT | ||
| Anchor (K061863 and K061665) and the Arthrex Biocorkscrew Anchor | ||
| (K061863 and K043337). | ||
| Device Classification | This device carries an FDA product code MBI and HWC, and is | |
| classified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth or | ||
| threaded metallic bone fixation fasteners under 21 CFR 888.3040. |
Confidential
1
Device Description
The Healix Ti Anchor is a non-absorbable threaded suture anchor manufactured of Titanium material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of #2 suture to bone. The anchor is provided in three sizes: one with an outer diameter of 4.5mm, another with an outer diameter of 5.5mm and the third with an outer diameter of 6.5mm. The suture options may or may not include tapered needles to facilitate suture passage through The Healix Anchors are currently offered with absorbable tissue. Panacryl, non-absorbable Ethibond or partially absorbable Orthocord suture options.
Indications for Use
The Healix Ti Anchor is intended for:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella tendon repair and secondary fixation in ACL / PCL reconstruction repair.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hip: Capsular repair, acetabular labral repair.
Safety and Performance
Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Healix Ti Anchor has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Premarket Notification: Traditional Healix Ti Anchor
Confidential
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features 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 evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Mitck A Johnson & Johnson company % Ms. Kristine Christo Regulatory Affairs Project Lead 325 Paramount Drive Raynham, Massachusetts 02767
NOV 0 7 2008
Re: K082282
Trade/Device Namc: Healix Ti Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, JDR Dated: August 8, 2008 Received: August 11, 2008
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.
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. Kristine Christo
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 the reporting 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
Page 1 of
x 1
510(k) Number (if known): K082282
Device Name: Healix Ti Anchor
Healix Anchor is indicated for use in the following:
Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella tendon repair and secondary fixation in ACL / PCL reconstruction
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hip: Capsular repair, acetabular labral repair.
(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 | K082282 |
|---|---|
| --------------- | --------- |
| Prescription Use | √ | OR | Over-the-Counter Use | ℵo |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
Premarket Notification: Traditional Healix Ti Anchor