Who is the manufacturer of GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE?

Depuy Mitek, A Johnson & Johnson Company filed the 510(k) submission for GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE (K051989).

What is the FDA product code for GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE?

JDR. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE

Q: What are the predicate devices for GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE?

GII Quickanchor Plus (K041115).

K051989 · Depuy Mitek, A Johnson & Johnson Company · JDR · Aug 5, 2005 · Orthopedic

Device Facts

Record ID	K051989
Device Name	GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
Applicant	Depuy Mitek, A Johnson & Johnson Company
Product Code	JDR · Orthopedic
Decision Date	Aug 5, 2005
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

GII Quickanchor Plus is a preloaded, metallic, disposable suture anchor/inserter assembly; facilitates soft tissue-to-bone fixation. Device consists of metal anchor identical in design/dimensions to predicate; preloaded with various suture types (Ethibond, Panacryl, or Orthocord). Used by surgeons in clinical/OR settings for orthopedic repairs. Surgeon inserts anchor into bone; suture secures soft tissue. Provides mechanical fixation to aid healing of tendons/ligaments.

Clinical Evidence

Bench testing only. Testing demonstrated that ORTHOCORD suture conformed to USP monograph for absorbable sutures; suture compatibility and deployment met predetermined acceptance criteria.

Technological Characteristics

Metallic bone anchor; preloaded disposable inserter assembly. Suture options include Ethibond, Panacryl, or Orthocord. Fixation principle: mechanical bone anchor. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for fixation of USP size #2 suture to bone for soft tissue repair in shoulder, ankle, foot, wrist, hand, elbow, and knee procedures, including ligament, tendon, and capsule reconstructions/repairs.

Regulatory Classification

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.

Predicate Devices

GII Quickanchor Plus (K041115)

Reference Devices

Ethibond Suture (NDA 17-804)
Panacryl Suture (K964345)
Orthocord Suture (K040004)
Orthocord Suture (K043298)

Related Devices

K052631 — SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) · Depuy Mitek, A Johnson & Johnson Company · Oct 21, 2005
K052630 — ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) · Depuy Mitek, A Johnson & Johnson Company · Oct 17, 2005
K080352 — MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE · Depuy Mitek, A Johnson & Johnson Company · Mar 12, 2008
K071257 — MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD · Depuy Mitek, A Johnson & Johnson Company · Jun 29, 2007
K063273 — PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR · Depuy Miltek, A Johnson & Johnson Co. · Nov 22, 2006

Submission Summary (Full Text)

{0}------------------------------------------------ K051989 page 142 AUG 5 - 2005 ## 510(k) SUMMARY ## GII Quickanchor Plus | Submitter's Name and Address: | DePuy Mitek a Johnson & Johnson company 249 Vanderbilt Avenue Norwood, MA 02062 | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Denise Luciano Senior Regulatory Affairs Specialist DePuy Mitek a Johnson & Johnson company 249 Vanderbilt Avenue Norwood, MA 02062 Telephone: 781-251-2794 Facsimile: 781-278-9578 e-mail: dluciano@dpyus.jnj.com | | Name of Medical Device | Classification Name: Screw, Fixation, Bone Staple Common/Usual Name: Appliance for reconstruction of soft tissue to bone Proprietary Name: GII Quickanchor Plus | | Substantial Equivalence | GII Quickanchor Plus (with ORTHOCORD) is substantially equivalent to: GII Quickanchor Plus, K041115, manufactured by DePuy Mitek. | | Device Classification | Bone anchors/screws are classified by the FDA as Class II Medical Devices under the generic category of Single/Multiple component metallic bone fixation appliances and accessories. GII Quickanchor Plus carry FDA product code JDR, and is classified as a fixation screw/bone staple under 21 CFR 888.3030. | | Device Description | 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 | | 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. | | Safety and Performance | The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria. Based on the indications for use, technological characteristics, and comparison to predicate devices, the GII Quickanchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. | {1}------------------------------------------------ Page 2/2 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298). {2}------------------------------------------------ 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 {4}------------------------------------------------ ## 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