Knee: Extra capsular repairs; reattachment of: medial collateral 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.

The DePuy 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 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.

The HEALIX Ti Dual Threaded Suture Anchor is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Hip: Capsular repair, acetabular labral repair.

Rotator Cuff Anchors: (I) SHOULDER 1. Rotator Cuff

The DePuy Mitek RC QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: Rotator cuff repair.

Super Anchors: (I) SHOULDER 1. Biceps tenodesis 2. Capsule shift/capsulolabral reconstruction 3. Deltoid repair 4. Rotator cuff (II) ANKLE 1. Achilles tendon repair/reconstruction (III) KNEE 1. Extra capsular reconstruction, ITB tenodesis 2. Joint capsule closure to anterior proximal tibia 3. Lateral collateral ligament 4. Medial collateral ligament 5. Patellar ligament and tendon avulsion repairs 6. Posterior oblique ligament or joint capsule to tibia

Device Description

The only proposition of this 510(k) submission is to add a generic "MR-Conditional" statement and symbol to the product package inserts and labels. There are no changes being made to the indications, product designs, material, packaging, and to the manufacturing processes.

AI/ML Overview

This document describes MRI safety testing for various DePuy Mitek metal implant devices. It is a 510(k) summary for adding an "MR-Conditional" statement and symbol to product labeling. It is not a study assessing the clinical performance of a diagnostic or therapeutic device using human data. Therefore, many of the requested categories related to clinical study design, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies, are not applicable.

Here's the information derived from the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Magnetic field interaction at 3.0 Tesla	"MR-conditional"
MRI-related heating at 3.0 Tesla	"MR-conditional"
Presence of artifacts at 3.0 Tesla	"MR-conditional"

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for each individual implant, but testing was performed on "DePuy Mitek metal implant devices" (plural), indicating multiple devices were tested.
Data Provenance: The tests were non-clinical (laboratory/engineering tests) rather than human or animal studies. The location of the testing facility or country of origin is not specified, but the submission is from DePuy Mitek, Inc. in Raynham, MA, USA, to the FDA. The tests are prospective in the sense that they were conducted specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. These were non-clinical engineering tests (magnetic field interaction, heating, artifacts), not clinical evaluations requiring expert interpretation of medical images or patient outcomes. The "ground truth" was established by the technical measurements themselves against defined standards for MRI compatibility.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This was a non-clinical engineering test, not a subjective assessment requiring human expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission concerns the MRI compatibility of medical implants, not the performance of AI-assisted diagnostic tools.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This relates to the physical properties of a medical device in an MRI environment, not an algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for these tests was established by objective physical measurements using MRI scanners and related equipment to assess magnetic field interaction, temperature change, and image artifact size, according to recognized standards for MRI compatibility (though the specific standards are not cited in this excerpt).

8. The sample size for the training set

Not applicable. There was no "training set" as this was not a machine learning model but rather a physical property test.

9. How the ground truth for the training set was established

Not applicable, as there was no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the DePuy Mitek Inc. logo, which is a Johnson & Johnson company. The logo includes the tagline "never stop moving." Above the logo, there is a handwritten number "K11/1631".

PRODUCT: MRI STATEMENT FOR METAL IMPLANTS SUBMISSION DATE: JUNE 06™, 2011 SUBMISSION TYPE: TRADITIONAL

5 I O(k) SUMMARY - DePuy Mitek MRI STATEMENT FOR METAL IMPLANTS

SUBMITTER'S NAME AND ADDRESS

JUL 2 2 2011

DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767

CONTACT PERSON

Deep Pal Regulatory Affairs Specialist DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767

TELEPHONE	508-828-3359
FACSIMILE	508-977-6911
E-MAIL	dpal3@its.jnj.com
DATE PREPARED	June 06th, 2011

NAME OF MEDICAL DEVICE

COMMON NAME

Bone Anchors, Screws

TRADE NAME/PROPRIETARY NAME

GII Anchor/Gll Quick Anchor Plus .
. Healix Ti Dual Threaded Suture Anchor
� Rotator Cuff Anchor/Rotator Cuff Quick Anchor Plus
. Super Anchor/Super Quick Anchor Plus

SUBSTANTIAL EQUIVALENCE

There are no changes being made to the indications, product designs, material, packaging, and to the manufacturing processes. The only proposition of this 510(k) submission is to add a generic "MR-Conditional" statement and symbol to the product package inserts and labels.

. K915889, K051989 - Gll Anchor/Gll Quick Anchor Plus
K082282 - Healix Ti Dual Threaded Suture Anchor .
. K992611, K052630 - Rotator Cuff Anchor/Rotator Cuff Quick Anchor Plus
. K930893, K052631 - Super Anchors/Super Quick Anchor Plus

p. 1 of 5

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Image /page/1/Picture/0 description: The image shows a handwritten string of numbers and letters. The string appears to be "K111631". The numbers are written in a simple, slightly slanted style. The letter K is written in uppercase.

Dep never stop moving

PRODUCT: MRI STATEMENT FOR METAL IMPLANTS SUBMISSION DATE: JUNE 06™, 2011 SUBMISSION TYPE: TRADITIONAL

5 I O(k) SUMMRY - DePuy Mitek MRI STATEMENT FOR METAL IMPLANTS

DEVICE CLASSIFICATION

•	GII Anchor/GII Quick Anchor Plus - K915889, K051989
○	Device Classification:	II
○	Device Classification Name:	Fastener, Fixation, Nondegradable, Soft tissueStaple, Fixation, Bone
○	Regulation Number:	888.3040-Smooth or threaded metallic bone fixation fastener888.3030-Single/multiple component metallic bone fixationappliances and accessories
○	Classification Product Code:	MBI, JDR
•	Healix Ti Dual Threaded Suture Anchor - K082282
○	Device Classification:	II
○	Device Classification Name:	Screw, Fixation, Bone
○	Regulation Number:	888.3040-Smooth or threaded metallic bone fixation fastener
○	Classification Product Code:	HWC
○	Subsequent Product Code:	JDR, MBI
•	Rotator Cuff Anchor/Rotator Cuff Quick Anchor Plus - K992611, K052630
○	Device Classification:	II
○	Device Classification Name:	Screw, Fixation, Bone
○	Regulation Number:	888.3040-Smooth or threaded metallic bone fixation fastener
○	Classification Product Code:	HWC
•	Super Anchor/Super Quick Anchor Plus - K930893, K052631
○	Device Classification:	II
○	Device Classification Name:	Staple, Fixation, Bone
○	Regulation Number:	888.3030-Single/multiple component metallic bone fixationappliances and accessories
○	Classification Product Code:	JDR
○	Subsequent Product Code:	JDR, MAI

p. 2 of 5

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Image /page/2/Picture/0 description: The image shows the DePuy Synthes logo, which includes the company name and tagline "never stop moving." Above the logo is the number K111631 written in black ink. The DePuy Synthes logo is a combination of text and a circular graphic element. The text "Mitek Inc. a Johnson & Johnson company" is also present below the logo.

PRODUCT: MRI STATEMENT FOR METAL IMPLANTS SUBMISSION DATE: JUNE 06 ", 2011 SUBMISSION TYPE: TRADITIONAL

5 I O(k) SUMMARY - DePuy Mitek MRI STATEMENT FOR METAL IMPLANTS

INDICATIONS FOR USE

. Gil Anchors

SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair.

ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Midfoot reconstructions.

FOOT: Hallux valgus reconstruction.

WRIST: Scapholunate ligament reconstruction.

HAND: Ulnar or lateral collateral ligament reconstruction.

ELBOW: Biceps tendon reattachment; Tennis elbow repair.

KNEE: Extra capsular reconstruction, ITB tenodesis; Lateral ligament; Patellar ligament and tendon avulsion repairs; Posterior oblique ligament or joint capsule to tibia; Joint capsule closure to anterior proximal tibia; Medial collateral ligament.

Gll Quick Anchor Plus

The DePuy Mitek Gll 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.

p. 3 of 5

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Image /page/3/Picture/0 description: The image shows the DePuy Synthes logo, which includes the company name in bold black letters. Below the logo, it says "a Johnson & Johnson company". To the right of the logo, the text "never stop moving" is visible. Above the logo, the text "K111631" is written in black ink.

PRODUCT: MRI STATEMENT FOR METAL IMPLANTS SUBMISSION DATE: JUNE 06™, 2011 SUBMISSION TYPE: TRADITIONAL

5 I Q(k) SUMMARY - DePuy Mitek MRI STATEMENT FOR METAL IMPLANTS

INDICATIONS FOR USE

Healix Ti Dual Threaded Suture Anchor
The HEALIX Ti Dual Threaded Suture Anchor is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular

Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament

Repair, Illiotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Hip: Capsular repair, acetabular labral repair.

Rotator Cuff Anchors

(1) SHOULDER

Rotator Cuff

Rotator Cuff Quick Anchor Plus

The DePuy Mitek RC QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 suture to bone for the indications listed below. Shoulder: Rotator cuff repair.

Super Anchors

(I) SHOULDER
1. Biceps tenodesis
1. Capsule shift/capsulolabral reconstruction
1. Deltoid repair
1. Rotator cuff
(II) ANKLE
1. Achilles tendon repair/reconstruction

(III) KNEE

1. Extra capsular reconstruction, ITB tenodesis
1. Joint capsule closure to anterior proximal tibia
1. Lateral collateral ligament
1. Medial collateral ligament
1. Patellar ligament and tendon avulsion repairs
1. Posterior oblique ligament or joint capsule to tibia

p. 4 of 5

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Image /page/4/Picture/0 description: The image shows the handwritten number sequence "1511631" at the top. Below this, the DePuy Synthes logo is displayed, accompanied by the tagline "never stop moving." The logo also includes the text "Mitek Inc. a Johnson & Johnson company" in a smaller font size.

PRODUCT: MRI STATEMENT FOR METAL IMPLANTS SUBMISSION DATE: JUNE 06™, 2011 SUBMISSION TYPE: TRADITIONAL

5 I O(k) SUMMARY - DePuy Mitek METAL IMPIANTS

INDICATIONS FOR USE

. Super Quick Anchor Plus

The DePuy Mitek Super QUICKANCHOR Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.

Ankle: Achilles tendon repair/reconstruction.

TECHNOLOGICAL CHARACTERSTICS

The only proposition of this 510(k) submission is to add a "MR-Conditional" statement and symbol to all applicable product package-inserts and labels. Technological characteristics including indications, product design, material, and packaging are the same as the predicate devices.

NONCLINICAL TESTING

MRI Testing using a scanner operating with a static magnetic field was performed on the DePuy Mitek metal implant devices. The test performed, included magnetic field interaction, MRI-related heating, and the presence of artifacts at 3.0 Tesla.

SAFETY AND PERFORMANCE

Results of "Evaluation of Magnetic Field Interactions, Heating, and Artifacts" have demonstrated that the currently marketed DePuy Mitek metal implants are "MR-conditional".

P. 5 of 5

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DePuy Mitek, A Johnson & johnson Company % Mr. Deep Pal Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767

Re: K111631

JUL 22 2011

Trade/Device Name: Super QUICKANCHOR® Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 6, 2011 Received: June 13, 2011

Dear Mr. Pal:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{6}------------------------------------------------

Page 2 - Mr. Deep Pal

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Ke Atther

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/7/Picture/0 description: The image shows the logo for DePuy Mitek Inc., a Johnson & Johnson company. The logo features the DePuy name in a bold, sans-serif font, with the tagline "never stop moving" in a smaller, italicized font. The logo is simple and modern, and it conveys a sense of movement and progress. The image is likely from a company document or website.

PRODUCT: SUBMISSION DATE: JUNE 06™, 2011 SUBMISSION TYPE: TRADITIONAL

MRI STATEMENT FOR METAL IMPLAN

INDICATIONS FOR USE FORM

510(k) Number (if known):

Device Names: Super QUICKANCHOR® Plus

Indications for Use:

The DePuy Mitek Super QUICKANCHOR Plus is intended for fixation of USP size #2 through #5 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair; capsular repair; biceps repair; deltoid repair.

Ankle: Achilles tendon repair/reconstruction.

Prescription Use V (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)

Page 1 of

for m. Melkerm

(Division Sign Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111631

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the DePuy Mitek Inc. logo, a Johnson & Johnson company, along with the slogan "never stop moving." The logo features the company name in a bold, sans-serif font, with a solid black circle to the left of the name. The slogan is written in a smaller, italicized font to the right of the logo.

PRODUCT: SUBMISSION DATE: JUNE 06 ", 2011 SUBMISSION TYPE: TRADITIONAL

MRI STATEMENT FOR METAL IMPLA

INDICATIONS FOR USE FO

510(k) Number (if known):

Device Names: GII™ Anchor

Indications for Use:

SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsublabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair.

ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions.

FOOT: Hallux valgus reconstruction.

WRIST: Scapholunate ligament reconstruction.

HAND: Ulnar or lateral collateral ligament reconstruction.

ELBOW: Biceps tendon reattachment; Tennis elbow repair.

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)

Page 1 of

for M. Mulker an

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K111631

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the DePuy Mitek Inc. logo, which is a Johnson & Johnson company. The logo is black and white and features the DePuy name in bold letters. Next to the logo is the phrase "never stop moving" in a cursive font. The image is a close-up of the logo and phrase.

MISSION DATE: JUNE 06™, 2011 SUBMISSION TYPE: TRADITIONAL

MRI STATEMENT FOR METAL IMPLANT

INDICATIONS FOR USE FO

510(k) Number (if known):

Device Names: GII™ QUICKANCHOR® Plus

Indications for Use:

The DePuy 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.

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)


--	--------------------------------------------

	Page 1 of 1
--	-------------

(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K111631
---------------	---------

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the DePuy Mitek Inc. logo, which is a black circle followed by the word "DePuy" in bold black letters. Below the logo, it says "Mitek Inc." and "a Johnson & Johnson company" in smaller letters. To the right of the logo, it says "never stop moving" in a cursive font.

PRODUCT: SUBMISSION DATE: JUNE 06™, 2011 SUBMISSION TYPE: TRADITIONAL

MRI STATEMENT FOR METAL IMPLANTS

INDICATIONS FOR USE FOR

510(k) Number (if known):

Device Names: HEALIX Ti™ Dual Threaded Suture Anchor

Indications for Use:

The HEALIX Ti Dual Threaded Suture Anchor is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Hip: Capsular repair, acetabular labral repair.

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)

Page 1 of

for M. Melkerm
(Division Sign Off)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K111631
510(k) Number

{11}------------------------------------------------

PRODUCT:	MRI STATEMENT FOR METAL IMPLANTS
SUBMISSION DATE:	JUNE 06TH, 2011
SUBMISSION TYPE:	TRADITIONAL

INDICATIONS FOR USE FORMS

510(k) Number (if known):	K11163)
Device Names:	ROTATOR CUFF ANCHOR

Indications for Use:

(I) SHOULDER

Rotator Cuff

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)

Page 1 of

for m. Melkion
(Division Sign(oft)

Division of/Surgical, Orthopedic,
Division of/Surgical, Orthopedic,
and Restorative Devices

510(k) Number K111621

{12}------------------------------------------------

PRODUCT:	MRI STATEMENT FOR METAL IMPLANTS
SUBMISSION DATE:	JUNE 06 TH , 2011
SUBMISSION TYPE:	TRADITIONAL

INDICATIONS FOR USE FORMS

510(k) Number (if known):	K111631
---------------------------	---------

Device Names: Rotator Cuff QUICKANCHOR® Plus

Indications for Use:

The DePuy Mitek RC QUICKANCHOR Anchor Plus is intended for fixation of USP size #2 suture to bone for the indications listed below.

Shoulder: Rotator cuff repair.

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)

Rage 1 of

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices	for M. Melkersom
510(k) Number	K111631

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the DePuy Mitek Inc. logo, which is a Johnson & Johnson company. The logo is black and white and features the words "DePuy Mitek Inc." in a bold font. The tagline "never stop moving" is written in a cursive font to the right of the logo. The logo is simple and modern.

PRODUCT: SUBMISSION DATE: JUNE 06™, 2011 SUBMISSION TYPE: TRADITIONAL

MRI STATEMENT FOR METAL IMPLANTS

INDICATIONS FOR USE FORMS

510(k) Number (if known):

Device Names: DePuy MITEK SUPERANCHOR

Indications for Use:

(I) SHOULDER

1. Biceps tenodesis
1. Capsule shift/capsulolabral reconstruction
1. Deltoid repair
1. Rotator cuff

(II) ANKLE

Achilles tendon repair/reconstruction

(III) KNEE

1. Extra capsular reconstruction, ITB tenodesis
1. Joint capsule closure to anterior proximal tibia
1. Lateral collateral ligament
1. Medial collateral ligament
1. Patellar ligament and tendon avulsion repairs
1. Posterior oblique ligament or joint capsule to tibia

Prescription Use V AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Page 1 of

(Division Sign Off) for M. Welker

Division Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111631

Regulation Number and Section

§ 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.