(83 days)
Not Found
Not Found
No
The 510(k) summary describes a bone anchor and inserter, a mechanical device for soft tissue fixation. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The focus is on substantial equivalence to predicate devices based on size and intended use.
Yes
The device is a bone anchor used for fixation of soft tissue to bone, which is a therapeutic purpose.
No
The device is a bone anchor used for fixation of soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "bone anchor with inserter," which are physical, hardware components used in surgical procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a bone anchor and inserter, which are physical implants and tools used in surgery. This aligns with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
The device is clearly described as a surgical implant used for structural support within the body.
N/A
Intended Use / Indications for Use
The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone.
Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Product codes (comma separated list FDA assigned to the subject device)
HTY
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, Elbow, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Not Found
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.
Not Found
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
Opus Medical, Inc.
510(k) Notification
MiniMagnum™ Bone Anchor and Instrument Set Page 9 of Sin
DEC 1 4 2004
Section 4: 510(k) Summary
510(k) Number:
page 1 of 2
Substantial Equivalence
Substantial Equitements of 21 CFR 807.93, this summary is formatted with the In accordance with the requirements and 510(k) Statements... " and can be used to provide equivalence summary to anyone requesting it from the Agency.
| Manufacturer: | Opus Medical, 27127 Calle Arroyo, Suite 1924
San Juan Capistrano, CA. 92675 |
|-----------------|----------------------------------------------------------------------------------------------|
| Contact Person: | Laura Kasperowicz, Ph: (949) 234-0400, Fax: 234-0493
E-Mail: Lkasperowicz@opusmedical.com |
| Date Prepared: | September 20, 2004 |
Device Information
| Trade Name: | Opus MiniMagnum™ Anchor with Inserter |
|---|---|
| Common Name: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Classification Name: | Fastener, Fixation, Non-degradable, Soft Tissue |
| Classification: | Class II per 21 CFR 888.3040; Product Code: HTY |
Substantial Equivalence
The Opus MiniMagnum™ Anchor with Inserter is substantially equivalent to the existing Opus Magnum™ Anchor with Inserter and the Mitek Bioknotless Anchor cleared by the Food and Drug Administration. Additionally, the intended use of the Opus MiniMagnum™ Anchor with Inserter is identical and therefore substantially equivalent to the intended use of the existing Mitek BioKnotless Anchor, for fixation of soft tissue to bone.
Indications For Use
The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone.
Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
1
Opus Medical, Inc.
510(k) Notification
Section 4: 510(k) Summary
510(k) Number: K045584
page 2 of 2
Executive Summary and Reason for 510(k) Notification
Executive Sullimary and Reason ior erra of a new Opus product, the Opus I he purpose of this STU(K) is to nothy the PDF of the " substantially equivalent to Opus MiniMagnum™ originally cleared under 510(k) 012125, but is smallers in size. The intended use and Magnum !™ originally cleared under 310(x) 012125, oat be Mick BioKnotless Bone Anchor.
indications for use are the same as the predicate device, the Michaetially indications for use are the same as the predicate do november System is substantially I he rundaniental technology of the Opus Magnum™ Bone Anchor.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle's perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Ms. Laura N. Kasperowicz Regulatory Affairs Opus Medical, Inc. 27127 Calle Arrovo, Suite 1924 San Juan Capistrano, California 92675
Re: K042584
Trade/Device Name: Opus MiniMagnum™ Bone Anchor with Inserter Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 21, 2004 Received: September 22, 2004
Dear Ms. Kasperowicz:
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.
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. Laura N. Kasperowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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.
Mark A. Mcllussen
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
Opus Medical, Inc.
510(k) Notification
SECTION 3: STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K042584
Device Name: Opus MiniMagnum™ Bone Anchor with Inserter
Indications for Use:
The Opus MiniMagnum™ bone anchor with inserter is indicated for use in fixation of soft tissue to bone.
Examples of such procedures include:
Ελαπίριο στ such proved. SLAP Iesion repair, acromio-clavicular separation, rotator cuff Onounter - Banklift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair 1 count, expons sinfe bappen one in instability, Achilles tendon repair/reconstruction, and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon reattachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique I's ligament or joint capsule co anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
Prescription Use X (Per CFR 801.109)
OR
Over-The-Counter Use No
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number