(39 days)
Not Found
No
The device description explicitly states that the only change is the addition of an "MR-Conditional" statement and symbol to the packaging, with no changes to the design, materials, or manufacturing processes. There is no mention of AI or ML in the document.
Yes
Explanation: The device, a suture anchor, is used for the fixation of sutures to bone for various repairs in musculoskeletal structures (e.g., rotator cuff repair, Achilles tendon repair). These are procedures aimed at treating or alleviating a medical condition, which aligns with the definition of a therapeutic device.
No
The device is a surgical anchor intended for fixation of sutures to bone for various repairs and reconstructions across different anatomical sites. It is not designed to diagnose conditions. The document describes testing for MRI compatibility, not diagnostic capability.
No
The device description explicitly states that the submission is for adding an "MR-Conditional" statement and symbol to product package inserts and labels for "metal implant devices". This indicates the device is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of suture to bone for various surgical repairs and reconstructions in different anatomical locations (shoulder, ankle, knee, etc.). This is a surgical implant, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description focuses on adding an "MR-Conditional" statement to the packaging, indicating it's a physical implant.
- Performance Studies: The performance studies described are related to the device's behavior in an MRI environment (magnetic field interaction, heating, artifacts), which is relevant for a surgical implant that might be exposed to MRI, not for an IVD.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a surgical tool/implant used directly in the body during a procedure.
N/A
Intended Use / Indications for Use
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.
Super QUICKANCHOR® 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.
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.
GII™ Anchor:
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.
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.
GII™ QUICKANCHOR® Plus: 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.
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 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
Rotator Cuff QUICKANCHOR® 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.
DePuy MITEK SUPERANCHOR:
(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
Product codes (comma separated list FDA assigned to the subject device)
MBI, JDR, HWC, MAI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle, Foot, Wrist, Hand, Elbow, Knee, Hip
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)
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.
Results of "Evaluation of Magnetic Field Interactions, Heating, and Artifacts" have demonstrated that the currently marketed DePuy Mitek metal implants are "MR-conditional".
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.
K915889, K051989, K082282, K992611, K052630, K930893, K052631
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.
Not Found
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
§ 888.3040 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.
0
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 |
| 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 tissue |
| Staple, Fixation, Bone | ||
| ○ | Regulation Number: | 888.3040-Smooth or threaded metallic bone fixation fastener |
| 888.3030-Single/multiple component metallic bone fixation | ||
| appliances 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 fixation |
| appliances 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
-
- Biceps tenodesis
-
- Capsule shift/capsulolabral reconstruction
-
- Deltoid repair
-
- Rotator cuff
- (II) ANKLE
-
- Achilles tendon repair/reconstruction
(III) KNEE
-
- Extra capsular reconstruction, ITB tenodesis
-
- Joint capsule closure to anterior proximal tibia
-
- Lateral collateral ligament
-
- Medial collateral ligament
-
- Patellar ligament and tendon avulsion repairs
-
- Posterior oblique ligament or joint capsule to tibia
p. 4 of 5
4
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.
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.
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
7
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.
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.
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.
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.
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.
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.
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;
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.
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
17
INDICATIONS FOR USE FORMS
510(k) Number (if known):
Device Names: DePuy MITEK SUPERANCHOR
Indications for Use:
(I) SHOULDER
-
- Biceps tenodesis
-
- Capsule shift/capsulolabral reconstruction
-
- Deltoid repair
-
- Rotator cuff
(II) ANKLE
- Achilles tendon repair/reconstruction
(III) KNEE
-
- Extra capsular reconstruction, ITB tenodesis
-
- Joint capsule closure to anterior proximal tibia
-
- Lateral collateral ligament
-
- Medial collateral ligament
-
- Patellar ligament and tendon avulsion repairs
-
- 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