(78 days)
Not Found
No
The device description and intended use are for a mechanical suture anchor and suture, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a suture anchor intended for fixation of suture to bone, which is a structural component used in surgical repairs, not a device that directly provides therapy or treatment itself.
No
The device is a suture anchor intended for fixation of suture to bone in various body parts for surgical repair procedures, not for diagnosing medical conditions.
No
The device description clearly identifies the device as a "Suture Anchor," which is a physical implant used in surgical procedures, not a software-only product.
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 device used for fixation of suture to bone in various anatomical locations (shoulder, foot/ankle, knee, hand/wrist, and elbow) for surgical procedures. This is a direct surgical intervention on the body.
- Device Description: The description details a suture anchor, which is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The MedShape Solutions, Inc., WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
- 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, Achilies Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The proposed WedgeLoc™ 2.5mm Suture Anchor and Opti-Fiber™ Suture has the same intended uses as our previously cleared predicate device in K091202. The proposed WedgeLoc™ 2.5mm Suture Anchor is an extension of sizes offered and is substantially equivalent to the WedgeLoc™ 180x Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, and the predicate Arthrex PushLock™ 2.5mm Suture Anchor, cleared under K063479, in which the basic features and intended uses are the same. In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ 2.5mm Suture Anchor are equivalent.
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): 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).
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
MEDSHAPE
SOLUTIONS
DEC - 9 2009
Special 510(k) Page 9 of 88
ગુજરાત
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Special 510(k) Summary
Special 510(k) Number: K092914
September 18th, 2009 Date Prepared:
This Special 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: MedShape Solutions, Inc. (MSS) 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318 Registration #10026693
- B. Company Contact: Jack Griffis Vice President, Research & Development (404) 583-6889 (cell) (404) 249-9158 (fax) Jack. Griffis@MedShapeSolutions.com
- C. Device Information: Trade Name: WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Suture Common Name: Suture Anchor
- Fastener, Fixation, Non-degradable, Soft Tissue D. Classification Name: HWC/MBI 21 CFR 888.3040
- E. Predicate Device(s): MSS, WedgeLoc™ 180x Suture Anchor with Opti-Fiber™ Suture, K091202 Arthrex PushLock™ 2.5mm Suture Anchor, K063479
- E. Labeling and Intended Use: No changes to the labeling or Instructions for Use have been made to the submitted information of the MedShape predicate per K091202.
The proposed WedgeLoc™ 2.5mm Suture Anchor and Opti-Fiber™ Suture has the same intended uses as our previously cleared predicate device in K091202. In particular, both devices are indicated for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Tenodesis. Acromio-Clavicular Separation Bicens Repair. Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
1
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Ligament Hand/Wrist: Scapholunate Reconstruction, Ulnar Collateral Ligament Reconstruction. Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction
- G. Substantial Equivalence Summary:
The proposed WedgeLoc™ 2.5mm Suture Anchor is an extension of sizes offered and is substantially equivalent to the WedgeLoc™ 180x Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, and the predicate Arthrex PushLock™ 2.5mm Suture Anchor, cleared under K063479, in which the basic features and intended uses are the same. In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ 2.5mm Suture Anchor are equivalent.
Any differences between the WedgeLoc™ 2.5mm Suture Anchor and the MedShape predicate WedgeLoc™ 180x or Arthrex PushLock™ Suture Anchor are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted. MedShape Sofutions. Inc. has determined that the proposed WedgeLoc™ 2.5mm Suture Anchor is substantially equivalent to the currently marketed device.
Jack Griffit Vice President. Research & Development
Image /page/1/Picture/11 description: The image shows the logo for Medshape Solutions. The word "MEDSHAPE" is in large, bold, sans-serif font. Below it, the word "SOLUTIONS" is in a smaller, sans-serif font. A line separates the two words.
1575 Northside Drive, Suite 440 Atlanta, GA 30318 404-249-9156 phone 404-249-9158 fax
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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 stylized image of an eagle with three lines representing its wings and tail feathers. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
DEC - 9 2009
MedShape Solutions c/o Mr. Jack Griffis Vice President. Research & Development 1575 Northiside Drive, Suite 440 Atlanta, Georgia 30318
Re: K092914
Trade/Device Name: WedgeLoc™ 2.5mm Suture Anchor and Opti-Fiber™ Sutures Regulation Number: 21 CFR 888.3040 . Regulation Name: Smooth or threaded metallic bone fixation fastner Regulatory Class: Class II Product Code:MBI, HWC Dated: November 16, 2009 Received: November17, 2009
Dear Mr. Griffis:
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
3
Page 2 - Mr. Jack Griffis
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.fdaggov/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,
Jonata Jr
Image /page/3/Picture/7 description: The image contains two words, "for" and "R". The word "for" is written in cursive and is located on the left side of the image. The letter "R" is capitalized and is located on the right side of the image.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number:
Device Name: WedgeLoc™ 2.5mm Suture Anchor and Opti-Fiber™ Sutures
Indications for Use:
The MedShape Solutions, Inc., WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
- Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilies Tendon Repair, Hallux Foot/Ankle: Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction
Prescription Use × (Part 21 CFR 801 Subpart D)
510(k) Number K092914
.. '
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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