(87 days)
No
The device description and intended use are for a physical suture anchor and associated instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
This device is a medical implant designed for reattaching soft tissue to bone, which is a therapeutic intervention.
No
The device is a resorbable suture anchor designed to attach soft tissue to bone, not to diagnose a condition.
No
The device description clearly details a physical, resorbable suture anchor made of L-Lactide / Glycolide material, along with associated instrumentation. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states this device is a "resorbable suture anchor designed to attach soft tissue to bone." It is a physical implant used in surgical procedures.
- Intended Use: The intended use is for "soft tissue reattachment procedures in the shoulder, wrist, elbow and knee." This involves surgical intervention, not laboratory testing of samples.
The device is a surgical implant, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The MicroMax™ Suture Anchor is intended for use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee. Specific indications are as follows:
Shoulder Indications:
- Bankart repair
- SLAP lesion repair
- Acromioclavicular (ACL) separation
- Rotator cuff repair
- Capsule repair or capsuloabral reconstruction
- Biceps tenodesis
- Deltoid repair
Wrist Indications:
- Scapholunate ligament reconstruction
Elbow Indications:
- Tennis elbow repair
- Ulnar or radial collateral ligament reconstruction
- Biceps tendon reattachment
- Medial and lateral repairs
Knee Indications (Extra-capsular repair):
- Medial collateral ligament repair
- Lateral collateral ligament repair
- Posterior oblique ligament repair
- Joint capsule closure
- Iliotibial band tenodesis reconstruction
- Patellar ligament/tendon repair
- Vastus medialis obliquus (VMO) muscle advancement
The device is pre-loaded with suture for use at the discretion of the physician.
Product codes
HWC
Device Description
This device is a resorbable suture anchor designed to attach soft tissue to bone. The resorbable fixation anchor is comprised of L-Lactide / Glycolide material. The poly L-Lactic/polyglycolic acid copolymer degrades by hydrolysis into L-lactic and glycolic acids. These hydrolytic products are then further degraded into carbon dioxide and water via the cellular Krebs cycle. The material and rarer degraged into carron anonial and o the predicate device, LactoSorb® L15 Soft Tissue Screw and Washer, K012572.
The suture anchor measures 3.0mm in diameter and 9.0mm in length. It is a two-piece assembly, consisting of a body and a head portion. The body portion engages the bone, which is enhanced by means of seven circumferential ribs. The ribs measure 3.25mm in diameter. In addition, the body has two wings, that when deployed will flange outward into the bone. Upon deployment, the diameter at the flanged wings is 4mm.
The head portion provides a means to drive the anchor in as well as to attach suture to the anchor. The anchor has an eyelet through the head portion to allow suture to pass through which will be used to fasten the tissue to bone. The device will be pre-loaded with any legally marketed, size 2 suture.
Instrumentation is provided for proper use and placement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Wrist, Elbow, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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)
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 2 1 2004
BIOMET
K040475-
page 1 of 2
510(k) Summary
Biomet Manufacturing Corp. Applicant/Sponsor: Contact Person: Kacy Arnold
Requlatory Specialist
MicroMax® Suture Anchor Proprietary Name:
Common Name: Suture Anchor
Fastener, Fixation, Biodegradable soft tissue, 888.3045 Classification Name:
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
LactoSorb® Soft Tissue Screw and Washer (K012572)
Device Description:
.
This device is a resorbable suture anchor designed to attach soft tissue to bone. The resorbable fixation anchor is comprised of L-Lactide / Glycolide material. The poly L-Lactic/polyglycolic acid copolymer degrades by hydrolysis into L-lactic and glycolic acids. These hydrolytic products are then further degraded into carbon dioxide and water via the cellular Krebs cycle. The material and rarer degraged into carron anonial and o the predicate device, LactoSorb® L15 Soft Tissue Screw and Washer, K012572.
The suture anchor measures 3.0mm in diameter and 9.0mm in length. It is a two-piece assembly, consisting of a body and a head portion. The body portion engages the bone, which is enhanced by means of seven circumferential ribs. The ribs measure 3.25mm in diameter. In addition, the body has two wings, that when deployed will flange outward into the bone. Upon deployment, the diameter at the flanged wings is 4mm.
The head portion provides a means to drive the anchor in as well as to attach suture to the anchor. The anchor has an eyelet through the head portion to allow suture to pass through which will be used to fasten the tissue to bone. The device will be pre-loaded with any legally marketed, size 2 suture.
Instrumentation is provided for proper use and placement of the device.
MAILING ADDRESS 120. Box 587 Warsaw, IN 46581 0587
.
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
()[+][()[)[+](()+[(+)[(+(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+)(+) 574.267.6639
FAX "" 1. 36 . " . 86 . " . 8 . "
E-MAIL biomer@bionnet.com
1
K040475-
page 2 of 2
Intended Use:
ed Use:
The MicroMax™ Suture Anchor is intended for use in soft tissue reattachment procedures in the The Fileronax - Specific indications are as follows:
Shoulder Indications:
- Bankart repair .
- SLAP lesion repair �
- Acromioclavicular (ACL) separation .
- Rotator cuff repair .
- Capsule repair or capsuloabral reconstruction .
- Biceps tenodesis, deltoid repair �
Wrist Indications:
- Scapholunate ligament reconstruction .
Elbow Indications:
- Tennis elbow repair .
- Ulnar or radial collateral ligament reconstruction .
- Biceps tendon reattachment .
- Medial and lateral repairs �
Knee Indications (Extra-capsular repair):
- Medial collateral ligament repair .
- Lateral collateral ligament repair .
- Posterior oblique ligament repair .
- Joint capsule closure .
- Iliotibial band tenodesis reconstruction .
- Patellar ligament/tendon repair .
- Vastus medialis obliquus (VMO) muscle advancement .
The device is pre-loaded with suture for use at the discretion of the physician.
Summary of Technologies: The MicroMax™ Suture Anchor technological characteristics (material and design) are similar to predicate devices.
Non-Clinical Testing: Mechanical testing was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
All trademarks are property of Biomet, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 symbol that resembles three wavy lines or streams, which is a common element in the department's branding.
Public Health Service
MAY 2 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kacy Arnold, RN, MBA Regulatory Specialist Biomet Manufacturing Corporation P.O. Box 587 Warsaw, Indiana 46581
Re: K040475
Trade/Device Name: MicroMax™ Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 23, 2004 Received: February 24, 2004
Dear Ms. Arnold:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerebate) to the enactment date of the Medical Device Amendments, or to conniser 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). and Cosmotion (110. (110.) that the device, subject to the general controls provisions of the Act. The I ou may, dierere, misions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device is elaboried (toval controls. Existing major regulations affecting your device can may be subject to Salental 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 r that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I vith 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. Kacy Arnold, RN, MBA
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with and you to begin mailioning of substantial equivalence of your device to a legally premarket notincation: The PDF intelling of 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 darno 12-7 301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. IMIsoranuming of reference to premaisonsibilities under the Act may be obtained from the Other general miorination on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
L. Mark A. Milliman
Celia M. Witten, Ph.D., M.D. 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):
Device Name:
MicroMax™ Suture Anchor
Indications For Use:
Indications for the MicroMax™ Suture Anchor include use in soft tissue reattachment procedures
in the MicroMax™ Suture Anchor inclinations and fallows: Indications for the Microriax - Sucare Andrews
in the shoulder, wrist, elbow and knee. Specific indications are as follows:
in the shoulder, wrist, elbow and knee. Specifi
Shoulder Indications.
- Bankart repair ●
- SLAP lesion repair ●
- Acromioclavicular (ACL) separation .
- Rotator cuff repair .
- Capsule repair or capsuloabral reconstruction ●
- Biceps tenodesis ◆
- Deltoid repair .
Wrist Indications:
- Scapholunate ligament reconstruction ●
Elbow Indications:
- Tennis elbow repair .
- Ulnar or radial collateral ligament reconstruction .
- Biceps tendon reattachment �
- Medial and lateral repairs .
Knee Indications (Extra-capsular repair):
- Medial collateral ligament repair .
- Lateral collateral ligament repair .
- Posterior oblique ligament repair .
- Joint capsule closure �
- Iliotibial band tenodesis reconstruction .
- Patellar ligament/tendon repair .
- Vastus medialis obliquus (VMO) muscle advancement �
The device is pre-loaded with suture for use at the discretion of the physician.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use no
(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
Mark A. Mullean
Division Sign-Off
Division of General, Restorati and Neurological Devices
510(k) Number