(56 days)
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.
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.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of performance metrics like accuracy, sensitivity, or specificity. Instead, the document is a 510(k) summary for a medical device (MINILOK QuickAnchor Plus and Mini QuickAnchor Plus with Orthocord sutures), which primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed devices.
The information provided includes:
- Device Description: Explains the nature of the anchors and sutures.
- Proposed Indications for Use: Specifies the medical conditions and anatomical locations for which the devices are intended.
- Safety Information: Mentions biocompatibility studies demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
- Substantial Equivalence: Lists predicate devices to which the current device is deemed substantially equivalent.
There is no mention of:
- A table of acceptance criteria and reported device performance in terms of clinical or technical metrics.
- Sample sizes for test sets, data provenance, or details about training sets.
- The number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used (e.g., pathology, outcomes data).
Therefore, based on the input document, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this type of information is not present in the provided 510(k) summary. These summaries historically focus on demonstrating equivalence through design, materials, and intended use to predicate devices, rather than presenting detailed prospective clinical trial data with specific performance metrics and acceptance thresholds.
{0}------------------------------------------------
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 RepairWrist: 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. |
:
.
..
.
{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)
§ 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.