(14 days)
The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Wrist: Scapholunate ligament.
Hand: Ulnar or lateral collateral ligament reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
GII Quickanchor Plus (with ORTHOCORD) is a preloaded, metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the GII Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
The GII Quickanchor Plus is a medical device designed for soft tissue repair to bone using a preloaded, metallic disposable suture anchor/inserter assembly. The following details the acceptance criteria and the study that demonstrates the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Orthocord suture conformance to USP monograph | Conformed to the USP monograph for absorbable sutures. |
| Suture compatibility with the Quickanchor Plus system | Met predetermined acceptance criteria. |
| Deployment of the Quickanchor Plus system | Met predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a distinct "test set" for the GII Quickanchor Plus separate from the general bench testing. The evaluation was based on conformance to consensus and voluntary standards and bench testing. Therefore, details regarding sample size for a specific test set, country of origin, or retrospective/prospective nature of the data are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The evaluation relies on "conformance to consensus and voluntary standards" and "bench testing" rather than expert-established ground truth on case data.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the testing described (bench testing for material conformance and system deployment), an adjudication method as typically applied to clinical or imaging datasets is not applicable or described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission is for a medical device (suture anchor), not an AI diagnostic tool that would typically involve human reader performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as the GII Quickanchor Plus is a physical medical device, not an algorithm or AI system. The "standalone" performance refers to the device's ability to meet its functional specifications during bench testing. The bench testing demonstrated that the Orthocord suture, suture compatibility, and deployment met predetermined acceptance criteria.
7. Type of Ground Truth Used
The ground truth used was based on:
- USP monograph for absorbable sutures: This serves as a standardized, objective benchmark for material properties.
- Predetermined acceptance criteria for suture compatibility and deployment: These are internal engineering specifications established to ensure the device functions as intended.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical implant, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set mentioned for this device.
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K051989 page 142
AUG 5 - 2005
510(k) SUMMARY
GII Quickanchor Plus
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Denise LucianoSenior Regulatory Affairs SpecialistDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-2794Facsimile: 781-278-9578e-mail: dluciano@dpyus.jnj.com |
| Name of Medical Device | Classification Name: Screw, Fixation, Bone StapleCommon/Usual Name: Appliance for reconstruction of soft tissue to boneProprietary Name: GII Quickanchor Plus |
| Substantial Equivalence | GII Quickanchor Plus (with ORTHOCORD) is substantially equivalentto:GII Quickanchor Plus, K041115, manufactured by DePuy Mitek. |
| Device Classification | Bone anchors/screws are classified by the FDA as Class II MedicalDevices under the generic category of Single/Multiple componentmetallic bone fixation appliances and accessories.GII Quickanchor Plus carry FDA product code JDR, and is classified asa fixation screw/bone staple under 21 CFR 888.3030. |
| Device Description | GII Quickanchor Plus (with ORTHOCORD) is a preloaded, metallicdisposable suture anchor/ inserter assembly designed to allow softtissue repair to bone. The metal anchor is an identical anchor as that ofthe GII Quickanchor Plus in design, configuration and dimensions.The anchor system may be sold with Ethibond Suture (NDA 17-804 |
| Indications for Use | The Mitek GII Anchor (QUICKANCHOR) is intended for fixation ofUSP size #2 suture to bone for the indications listed below. |
| Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicularseparation, rotator cuff repair, capsule shift/capsulo-labralreconstruction, biceps tenodesis, deltoid repair. | |
| Ankle: Lateral instability, medial instability, achilles tendonrepair/reconstruction, midfoot reconstruction. | |
| Foot: Hallux valgus reconstruction. | |
| Wrist: Scapholunate ligament. | |
| Hand: Ulnar or lateral collateral ligament reconstruction. | |
| Elbow: Tennis elbow repair, biceps tendon reattachment. | |
| Knee: Extra capsular repairs; Reattachment of: medial collateralligament, lateral collateral ligament, posterior oblique ligament or jointcapsule to tibia and joint capsule closure to anterior proximal tibia;extra capsular reconstruction, ITB tenodesis; patellar ligament andtendon avulsions. | |
| Safety and Performance | The determination of substantial equivalence for this device was basedon a detailed device description, and conformance to consensus andvoluntary standards. Bench testing was performed demonstrating thatthe ORTHOCORD suture conformed to the USP monograph forabsorbable sutures, and the suture compatibility and deployment metpredetermined acceptance criteria.Based on the indications for use, technological characteristics, andcomparison to predicate devices, the GII Quickanchor Plus has beenshown to be substantially equivalent to predicate devices under theFederal Food, Drug and Cosmetic Act. |
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and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.
AUG 5 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Denise Luciano Senior Regulatory Affairs Specialist 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 DePuv Mitek a Johnson & Johnson company 249 Vanderbilt Avenue Norwood. Massachusetts 02062
K051989 Re: Trade/Device Name: GII Quickanchor Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: July 21, 2005 Received: July 22, 2005
Dear Ms. Luciano:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications forchered a do re and more sure) to legally marketed predicate devices marketed in interstate for use sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to esminered prior to may 2011-11-11 accordance with the provisions of the Federal Food, Drug, de necs mat have been rout do not require approval of a premarket approval application (PMA). and Coometer Fee (110) market the device, subject to the general controls provisions of the Act. The I ou may a me securitions 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 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.
{3}------------------------------------------------
Page 2 – Ms. Denise Luciano
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manistang your antial equivalence of your device to a legally premarket notification. The PDF Innaing of basification 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 If you desire specific advice for your aconcerner of 2012 . Also, please note the regulation entitled, and colliation of Compilance w (21 to 10 millication" (21CFR Part 807.97). You may obtain "Misbranding by Telefence to premained nothlited.com "(2) the Act may from the Division of Small other general information on your responsible in total-free number (800) 638-2041 or 10-Manufacturers, International and Colisanter Fibraw. For.gov/cdrh/industry/support/index.html
Sincerely yours,
Sturt Murkeron
Mark N. Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K0851989
Device Names: GII Quickanchor Plus
Indications for Use:
The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Wrist: Scapholunate ligament.
Hand: Ulnar or lateral collateral ligament reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Htyt Rhodes
storative. Page 1 of and Neurologic
Confidential
§ 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.