(82 days)
Not Found
No
The document describes a mechanical bone anchor and inserter, with no mention of software, algorithms, or any terms related to AI/ML.
No
The device is a bone anchor used for fixation of soft tissue to bone during surgical procedures, which is a structural component of surgery rather than a therapy itself.
No
Explanation: The device is described as a bone anchor with an inserter, indicated for the fixation of soft tissue to bone in various orthopedic procedures. Its function is to facilitate physical fixation, not to diagnose medical conditions or analyze patient data.
No
The device description explicitly states it is a "bone anchor with inserter handle," which are physical hardware components, not software.
Based on the provided information, 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 and Intended Use: The description clearly states that the Opus® Magnum™ PI bone anchor is a device used for the fixation of soft tissue to bone during surgical procedures. It is a physical implant and insertion tool, not a test performed on a biological sample.
- Lack of IVD Characteristics: The information does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, the Opus® Magnum™ PI bone anchor is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Opus® Magnum™ PI 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 attachment
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)
MBI, HWC
Device Description
The Opus Magnum™ PI device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
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.
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).
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§ 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.
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Ko70227 pge 'f²
510(K) SUMMARY
ARTHROCARE CORPORATION OPUS MAGNUM PI KNOTLESS FIXATION DEVICE
APR 16 2007
General Information
| Submitter Name/Address: | ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-3523 |
|---------------------------------|-----------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 2951580 |
| Contact Person: | Laura N. Kasperowicz
Sr. Manager, Regulatory Affairs |
| Date Prepared: | January 23, 2007 |
| Device Description | |
| Trade Name: | Opus® Magnum™ PI |
| Generic/Common Name: | Bone Anchor, Fastener, Fixation, Soft Tissue |
| Classification Name: | Fastener, Fixation, Nondegradeable, Soft Tissue
(Class II per 21 CFR 888.3040, Product code: MB) |
| Predicate Devices | |
| Opus Magnum | K012125 (Cleared 09/17/01) |
| Opus LabraLock P | K061349 (Cleared 07/14/06) |
Product Description
The Opus Magnum™ PI device is a bone anchor with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
Indications For Use
The Opus® Magnum™ PI 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 attachment
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
pge yf2
510(K) SUMMARY
Substantial Equivalence
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The Opus® Magnum™ PI design and technology is substantially equivalent to the existing Opus® Magnum™ Knotless Fixation Device cleared by the Food & Drug Administration [K012125, and subsequently amended by K020172, K031083 and K042914]. The Opus" Magnum™ PI material is substantially equivalent to the existing Opus" LabraLock™ P Knotless Fixation Device cleared by the Food & Drug Administration [K061349]. The differences between the Opus® Magnum™ PI and the predicate devices do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The device, as designed, is as safe and effective as predicate devices.
Summary and Reason for 510k Notification
The purpose of this 510k is to notify the Food and Drug Administration of a new product, the Opus Magnum™ PI Knotless Fixation Device. This new product is substantially equivalent to the Opus® Magnum™ Knotless Fixation Device originally cleared under K012125 [and subsequently amended by K020172. K031083 and K042914], but is manufactured from PEEK (polyether-etherketone) as opposed to stainless steel.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ArthroCare Corporation % Ms. Laura N. Kasperowicz Senior Manager, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523
APR 1 6 2007
K070227 Trade/Device Name: Opus® Magnum™ PI Knotless Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: January 23, 2007 Received: January 24, 2007
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.
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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" (21 CFR Part 807.97). 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 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Darbar Bonchum
Mark N. Melk Difector . Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Opus™ Magnum™ PI Knotless Fixation Device
Indications for Use:
The Opus® Magnum™ PI 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 attachment
KO 7022
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
X
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C) NO
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchus
Division of Ger neral, Restorative. and Neurological Devices
510(k) Number K070227