(92 days)
No
The device description and performance studies focus on the mechanical properties and surgical application of a suture anchor, with no mention of AI or ML.
Yes
The device is intended for the repair and reattachment of tissues to bone, which constitutes a therapeutic intervention.
No
Explanation: The device description indicates that the SpiraLok Anchor is a surgical implant used for reattaching soft tissue to bone. Its intended uses are for various repairs and reconstructions, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly describes a physical, implantable medical device (a PLA threaded suture anchor) and its associated disposable inserter assembly. It is not a software-only device.
Based on the provided information, the SpiraLok Anchor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for fixing sutures to bone to reattach soft tissue. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implant (suture anchor) and its associated components for surgical implantation.
- 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 samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The SpiraLok Anchor is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The SpiraLok Anchor is intended for: Shoulder: Rotor Cuff Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair; 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.
Product codes (comma separated list FDA assigned to the subject device)
87 MAI, HWC
Device Description
The SpiraLok Anchor is a PLA threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture to bone. Ethibond non-absorbable suture, the Panacryl absorbable suture and the Orthocord composite suture options may include tapered needles to facilitate suture passage through tissue. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Elbow
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 laboratory testing was performed demonstrating that the device is safe and can be considered substantially equivalent to the predicate Arthrex Bio-Corkscrew Suture Anchor for the proposed new intended uses.
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.
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
MAY - 4 (2005
K060271 SECTION 6 – 510(k) SUMMARY
Page 1 of 2
| Submitter's Name and Address: | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive,
Raynham, MA 02767 USA |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth Forstadt, RAC
Project Management Lead, Regulatory Affairs
DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive,
Raynham, MA 02767 USA
Telephone: (508) 977-3988
Facsimile: (508) 828-3750
e-mail: rforstad@dpyus.jnj.comT |
| Name of Medical Device | UUUUUUUUUUUUDevice Regulation:
Fastener, Fixation, Biodegradable, Soft Tissue
(21 CFR 888.3030)
Product code: 87 MAI
Common/Usual Name:
Biodegradable Fixation Fastener
Proprietary Name:
SpiraLok Anchor |
| Device Classification | In accordance with per 21 CFR 888.3030 suture anchors are classified
by the FDA as Class II Medical Devices. |
| Indications for Use | The SpiraLok Anchor is intended for: Shoulder: Rotor Cuff Repair,
Biceps Tenodesis, Acromio-Clavicular Separation Repair; 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. |
| Device Description | The SpiraLok Anchor is a PLA threaded suture anchor preloaded on a
disposable inserter assembly intended for fixation of two strands of
suture to bone. Ethibond non-absorbable suture, the Panacryl
absorbable suture and the Orthocord composite suture options may
include tapered needles to facilitate suture passage through tissue. The
attached suture is then used to reattach soft tissue back to bone where it
reconnects through the healing process. |
| Substantial Equivalence | The SpiraLok Anchor is a commercially marketed device that was
subject of K041069 (cleared November 9, 2004). When used for the
proposed indications the device is substantially equivalent to the
Arthrex Bio-Corkscrew Suture Anchor (K003227, cleared 1/8/2001). |
| Safety and Performance | The determination of substantial equivalence for this device was based
on a detailed device description. Non-clinical laboratory testing was
performed demonstrating that the device is safe and can be considered
substantially equivalent to the predicate Arthrex Bio-Corkscrew Suture
Anchor for the proposed new intended uses. |
1
K06 0271 510(k) SUMMARY
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle. The logo is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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DePuy Mitek c/o Ms. Ruth Forstadt, RAC Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
MAY - 4 2006
Re: K060271 Trade/Device Name: SpiraLok Absorbable Threaded Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HWC, MAI Dated: January 31, 2006 Received: February 1, 2006
Dear Ms. Forstadt:
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. Ruth Forstadt, RAC
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Hukut Lemevios
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K060271
Device Name:___SpiraLok Absorbable Threaded Suture Anchor
Indications For Use:
The Spiralok Anchor is intended for:
- Shoulder: Rotator Cuff Repair, Biceps Tenodesis, Acromio-Clavicular Separation . Repair
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair .
- Knee: Medial Collateral Ligamet Repair, Lateral Collateral Ligament Repair, . Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament . Reconstruction.
Prescription Use 7 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helbert Lerner
(Divisio Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K060271