(90 days)
No
The document describes a mechanical suture anchor and does not mention any AI or ML components or functionalities.
No
The device is a suture anchor intended for fixation, not for treating a disease or condition itself.
No
The device is described as a "Suture Anchor" intended for the fixation of suture and/or soft tissue to bone in various anatomical locations. Its function is to facilitate repair and reconstruction procedures, not to diagnose a condition.
No
The device description and intended use clearly indicate a physical suture anchor, which is a hardware component used for fixation in surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to fix suture and soft tissue to bone during various orthopedic procedures. This is an in-vivo application (within the living body).
- Device Description: The description refers to a "Suture Anchor," which is a physical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted within the body to provide structural support.
N/A
Intended Use / Indications for Use
The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures: Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction; Foot/Ankle Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy; Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction; Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.
Product codes
MBI
Device Description
The EXTREMITY MEDICAL Suture Anchor
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, elbow
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)
Not Found
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 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
510(k) Summary of Safety and Effectiveness:
JAN 2 2 2009
EXTREMITY MEDICAL Implant System
| Submitter | EXTREMITY MEDICAL LLC
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jamy Gannoe
President
Phone 973-588-8980
Email jgannoe@extremitymedical.com |
| Date Prepared | December 18, 2008 |
| Trade Name | EXTREMITY MEDICAL Suture Anchor |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener
21 CFR 888 3040 |
| Product Code | MBI |
| Predicate Devices | 1 Orthopaedic Biosystems Ltd, Inc (Smith & Nephew)
TwinFix Tı 2 8 Suture Anchor K972326
2 Smith & Nephew TwinFix PK FP Suture Anchor
K073509 |
| Device Description | The EXTREMITY MEDICAL Suture Anchor |
| Indications for use | The Extremity Medical Suture Anchor is intended for the
fixation of suture and/or soft tissue to bone in the shoulder,
foot/ankle, knee, hand/wrist, elbow in the following procedures
Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion
Repair, Biceps Tenodesis, Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular Shift of Capsulolabral
Reconstruction
Foot/Ankle Lateral Stabilization, Medial Stabilization, Achilles
Tendon Repair, Hallux Valgus Reconstruction, Mid-foot |
| | |
| | reconstruction, Metatarsal Ligament Repair/Tendon Repair,
Bunionectomy |
| | Knee Medial Collateral Ligament Repair, Lateral Collateral
Ligament Repair, Patellar Tendon Repair, Posterior Oblique
Ligament Repair, Iliotibial Band Tenodesis |
| | Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or
Radial Collateral Ligament Reconstruction |
| | Elbow Biceps Tendon Reattachment, Tennis Elbow Repair,
Ulnar or Radial Collateral Ligament Reconstruction |
| Statement of
Technological
Comparison | The EXTREMITY MEDICAL Suture Anchor and its predicate
devices have the same indications for use have a similar design
and are made of the similar materials |
| Conclusion | The EXTREMITY MEDICAL Suture Anchor is substantially
equivalent to its predicate devices This conclusion is based
upon the fact that this device is substantially equivalent in terms
of indications for use, materials, design and principles of
operation |
1
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Extremity Medical, LLC % Mr Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
JAN 2 2 2009
Re K083151
Trade/Device Name EXTREMITY MEDICAL Suture Anchor Regulation Number 21 CFR 888 3040 Regulation Name Smooth or threaded metallic bone fixation fastener Regulatory Class II Product Code MBI Dated October 22, 2008 Received October 24, 2008
Dear Mr Gannoe
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 adultcration
It 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 In tound 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 - Mr Jamy Gannoe
This letter will allow you to begin marketing your device as described in your Section 510(k) This lefter will allow you to begin makemily of substantial equivalence of your device to a legally
promatics notification The FDA finding of substance and thus, permits vo prematication - The PDA miding of Substantial squar device and thus, permits your device 10 proceed to the market
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please at if you desire specific advice for your device on our car as a this (CDRH's) Office of Complance at
contact the Center for Devices and Radiological Health is (CDRH) adapo by r Colliact the Content for Doviets and the regulation entitled, "Misbranding by reference to (240) 276-0120 Also, prease note the regulation regulations regarding postmarket surveillance, premarket nothcation (21CPK Pat 067 97) please contact CDRF's Office of Burvemance and the reportung of device adverse events.
Surveillance at 240-276-3474 For questions regarding the reportung of developes at 24 (Medical Device Reporting (MDR)), please contact the Division of Survelliance Systems at 240-(Medical Device Reporting (MDX)); production on your responsibilities and the Act from
276-3464 You may obtain other general information on your responsibilities and the Ac 270-5404 - You may obtain other general michiner and Consumer Assistance at its toll-free the DIVATOR OF Small Mar (240) 276-3150 or at its Internet address http //www fda gov/cdrh/industry/support/index html
Sıncerely yours,
Mark N Mulkerson
Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Suture Anchor EXTRE
510(k) Number (if known) Device Name Indications for Use•
The Extremity Medical Suture Anchor is intended for the fixation of suture and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures
Shoulder Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift of Capsulolabral Reconstruction Foot/Ankle Lateral Stabılızatıon, Medial Stabılızatıon, Achılles Tendon Repar, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Reparr, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction Filbow Biceps Tendon Reattachment, Tennis Elbow Repar, Ulnar or Radial Collateral Ligament
| Reconstruction |
|---|
| ---------------- |
| Prescription Use X AND/OR Over-the-counter |
|---|
| ---------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division of General Restorative.
and Neurological Devices
| 21 510(k) Number | K083157 |
|---|---|
| ------------------ | --------- |