(56 days)
No
The device description and intended use describe a mechanical anchor and inserter assembly for soft tissue to bone fixation. There is no mention of AI/ML in the text, and the "Mentions AI, DNN, or ML" field is "Not Found".
Yes
The device is indicated for "soft tissue to bone fixation," which is a medical intervention aimed at treating a biological condition (e.g., Bankart Repair, ligament reconstruction) to restore health or improve function.
No
Explanation: The device is described as an implant used for soft tissue to bone fixation, not for diagnosing medical conditions. Its intended use focuses on surgical repair and support.
No
The device description clearly states it is a "preloaded disposable anchor/inserter assemblies designed to facilitate the delivery and installation of the anchor into bone," indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a device used for surgical fixation of soft tissue to bone within the body. It's an implantable device used during a surgical procedure.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, based on the provided information, the MINI QuickAnchor Plus and MINILOK QuickAnchor Plus are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Shoulder: Bankart Repair
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.
The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC, NEW, GAT, JDR
Device Description
The MiniQuick Anchor Plus w/ Orthocord, and MINILOK QuickAnchor w/ Orthocord, are preloaded disposable anchor/inserter assemblies designed to facilitate the delivery and installation of the anchor into bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Wrist, Hand, Foot, Ankle
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)
Biocompatibility studies have demonstrated the MiniQuick Anchor Plus w/ Orthocord, MINILOK QuickAnchor w/ Orthocord, to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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K071257 pg 1 of 2
JUN 2 9 2007
SECTION 2 - 510(k) SUMMARY revised 6/13/07
MINILOK QuickAnchor Plus with Orthocord Mini QuickAnchor Plus with Orthocord
Address:
Contact Person
Submitter's Name and DePuy Mitek a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Kristine Christo Senior Regulatory Affairs Associate DePuv Mitek a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Telephone: 508 828-3359 508 977-6911 Facsimile: e-mail: KChristo@Dpyus.jnj.com Name of Medical Device Fastener, Fixation, Biodegradable, Soft Tissue Classification Name: Common/Usual Name: Bone Anchor Proprietary Name: MINILOK QuickAnchor Plus Classification Name: Smooth or threaded metallic bone fixation fastener Common/Usual Name: Bone Anchor Proprietary Name: Mini QuickAnchor Plus Classification Name: Absorbable PDS suture, nonabsorbable polyethylene suture Common/Usual Name: Suture Proprietary Name: Orthocord Suture Substantial Equivalence MINI QuickAnchor Plus w/ Orthocord, MINILOK QuickAnchor w/
Orthocord, and Orthocord Suture size 2-0, are substantially equivalent to: Mini QuickAnchor Plus (K930892, K992487 and K992623): MINILOK Quick Anchor Plus (K030995); and Orthocord Suture Size 2 (K043298, K04004) manufactured by DePuy Mitek. Bone anchors/screws are classified by FDA as a Class II Medical Devices under Device Classification the generic categories of Single/Multiple Component Metallic Bone Fixation Appliances, Orthopedic
Devices Panel (reference 21 CFR §888.3030). Product code MAI. ,
Smooth or threaded metallic fastener (reference 21 CFR §888.3040)
1
page 2 of 2
:
| Product code: | HWC |
|---|---|
| Sutures are classified by the FDA as Class II Medical Devices under the category of absorbable polydioxanone surgical suture(reference 21 CFR §878.4840) Product code:NEW, GAT |
| Device Description | The MiniQuick Anchor Plus w/ Orthocord, and MINILOK QuickAnchor w/ Orthocord, are preloaded disposable anchor/inserter assemblies designed to facilitate the delivery and installation of the anchor into bone. |
|---|---|
| Proposed Indications for Use | The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: |
| Shoulder: Bankart Repair | |
| Wrist: Scapholunate ligament reconstruction. | |
| Hand: Thumb ulnar or radial collateral ligament. | |
| Foot: Hallux valgus reconstruction. | |
| Ankle: Midfoot reconstruction. |
The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction. |
| Safety | Biocompatibility studies have demonstrated the MiniQuick Anchor Plus w/ Orthocord, MINILOK QuickAnchor w/ Orthocord, to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic. |
:
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Mitek a Johnson & Johnson company % Ms. Kristine Christo Senior Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
JUN 2 9 2007
Re: K071257
Trade/Device Name: MINILOK QuickAnchor Plus with Orthocord Mini QuickAnchor Plus with Orthocord Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, HWC, MAI Dated: May 3, 2007 Received: May 4, 2007
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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 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 2
INDICATIONS FOR USE revised 6/13/07
510(k) Number (if known): K071257
Device Name(s): MINILOK QuickAnchor Plus w/ Orthocord
Indications for Use:
The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Wrist: Scapholunate ligament reconstruction. Hand: Thumb ulnar or radial collateral ligament. Foot: Hallux valgus reconstruction. Ankle: Midfoot reconstruction.
Prescription Use X ___________________________________________________________________________________________________________________________________________________________
or
Over-the-Counter Use No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dd
Division Sign-Off Division of General, Restorative, and Neurological Devices
- Number
5
INDICATIONS FOR USE revised 6/13/07
510(k) Number (if known): K071257
Device Name(s): MINI QuickAnchor Plus w/ Orthocord
Indications for Use:
The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Shoulder: Bankart Repair Wrist: Scapholunate ligament reconstruction. Hand: Thumb ulnar or radial collateral ligament. Foot: Hallux valgus reconstruction. Ankle: Midfoot reconstruction.
Prescription Use ____x______x
or or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) . . . : المستقل المستقل المستوى الموضوع الموضوع الموضوع الموضوع الموضوع المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المستوى المست
Concurrence of CDRH, Office of Device Evaluation (ODE)