(87 days)
Not Found
No
The device description and intended use clearly define a physical, non-absorbable suture anchor made of PEEK material. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The performance studies focus on mechanical properties like torque and pull-out strength, not algorithmic performance.
No
The device is a PEEK anchor used for fixation of suture to bone during various surgical repairs, making it a surgical implant rather than a therapeutic device that delivers therapy.
No
Explanation: The device is described as a non-absorbable threaded suture anchor used for fixation of sutures to bone during surgical repairs (e.g., rotator cuff repair, ligament repair). Its purpose is mechanical support, not to diagnose a condition.
No
The device description clearly states it is a "non-absorbable threaded suture anchor manufactured of PEEK material" and comes "preloaded on a disposable inserter assembly," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- HEALIX ADVANCE PEEK Anchor Function: The description clearly states that this device is a "non-absorbable threaded suture anchor" used for "fixation of size 2 suture to bone." Its purpose is to physically attach tissue to bone during surgical procedures.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and surgical.
The information provided describes a surgical implant used for orthopedic repairs, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE™ PEEK Anchor is indicated for:
Shoulder: Rotator 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;
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)
HWC
Device Description
The HEALIX ADVANCE™ PEEK Anchor is non-absorbable threaded suture anchor manufactured of PEEK material. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size 2 suture to bone. The suture options may include needles to facilitate suture passage through tissue. HEALIX ADVANCE PEEK Anchor is provided sterile and is for single patient, use only.
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)
Non-clinical Testing
Design verification activities, such as Anchor Torque and Anchor Pull Out were performed against pre-defined acceptance criteria according to the indicated use. Results of performance 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 HEALIX ADVANCE PEEK Anchor 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.
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.
0
K120449 (pg1/2)
SECTION 2 - 510(k) SUMMARY
HEALIX ADVANCE™ PEEK Anchor
MAY 1 1 2012
ﺴﺮ ﺑﺎﻟﻤﺮﺍﺟﻊ -
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Yayoi Fujimaki
Regulatory Affairs Senior Associate
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3541
Facsimile: 508-977-6911
e-mail: yfujimal@its.jnj.com |
| Name of
Medical Device | Proprietary Name: HEALIX ADVANCE™ PEEK Anchor
Classification Name: Smooth or threaded metallic bone fixation fasteners
Common Name: Bone Anchor |
| Substantial
Equivalence
Facility | The HEALIX ADVANCE PEEK Anchor is substantially equivalent to:
• K071481: Healix PEEK Anchor |
| Device
Classification | Smooth or threaded metallic bone fixation fasteners, classified as Class II, product
code HWC, regulated under 21 CFR 888.3040. |
Premarket Notification: Traditional
HEALIX ADVANCE™ PEEK Anchor
, i
1
| Device
Description | The HEALIX ADVANCE PEEK Anchor is non-absorbable threaded suture anchor
manufactured of PEEK material. The anchor comes preloaded on a disposable inserter
assembly and is intended for fixation of size 2 suture to bone. The suture options may
include needles to facilitate suture passage through tissue. HEALIX ADVANCE
PEEK Anchor is provided sterile and is for single patient, use only. | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Shoulder: | Rotator 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; |
| | Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction; |
| | Hip: | Capsular repair, Acetabular Labral Repair. |
| Safety and
Performance | Non-clinical Testing
Design verification activities, such as Anchor Torque and Anchor Pull Out were
performed against pre-defined acceptance criteria according to the indicated use.
Results of performance 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 HEALIX ADVANCE PEEK Anchor 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 United States Department of Health and Human Services. The logo features a stylized eagle in flight, rendered in blue lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek, Inc a Johnson and Johnson Company % Ms. Yayoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, MA 02767
JUL - 2 2012
Re: K120449
Trade/Device Name: HEALIX ADVANCE™ PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 11, 2012 Received: May 11, 2012
Dear Ms. Fujimaki:
This letter corrects our substantially equivalent letter of May 11, 2012.
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 (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
3
Page 2 - Ms. Yayoi Fujimaki
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 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,
Mark A. Milkeron
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
KIZD449 (pa 1/1) 510(k) Number (if known): Device Name: HEALIX ADVANCE™ PEEK Anchor Indications for Use:
The HEALIX ADVANCE™ PEEK Anchor is indicated for:
| Shoulder: | Rotator 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; |
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction; |
| Hip: | Capsular repair, Acetabular Labral Repair. |
Prescription Use ____x
AND/OR
Over-The-Counter Use _
(Pari 21 CFR 801 Subpart D)
(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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120449
Page 1 of 1
Premarket Notification: Traditional HEALIX ADVANCE™ PEEK Anchor