(145 days)
No
The document describes a mechanical suture anchor and suture system, with no mention of AI or ML capabilities.
No.
The device is a suture anchor and sutures used for fixation of suture to bone in various anatomical regions, which is a surgical tool, not a therapeutic device designed for the treatment or cure of an ailment.
No
Explanation: The device, a suture anchor, is used for the fixation of sutures to bone in various repair and reconstruction procedures. Its intended use is therapeutic (repair/reconstruction) and does not involve diagnosing medical conditions.
No
The device description clearly identifies it as a "Suture Anchor with Opti-Fiber™ Sutures," which are physical medical devices used for fixation in surgical procedures. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used in vitro (outside the body).
- The description of the WedgeLoc™ 180X Suture Anchor clearly indicates it is a surgical implant used to fix suture to bone within the body. It is used in vivo (inside the body).
The intended use and device description describe a surgical device, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The MedShape Solutions, Inc., WedgeLoc™ 180X 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, Achilles 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
HWC, MBI, GAT
Device Description
WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures
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
Prescription Use (Part 21 CFR 801 Subpart D)
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
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
K091202 (pg 1/2)
Image /page/0/Picture/1 description: The image shows the logo for Medshape Solutions. The word "MEDSHAPE" is in large, bold, black letters on the top line. Underneath the first word is a horizontal line, and below that is the word "SOLUTIONS" in smaller, black letters.
SEP 16 2009
Special 510(k) Page 10 of 140
Special 510(k) Summary
Special 510(k) Number:
April 23rd, 2009 Date Prepared:
This Special 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- Submitter: A. MedShape Solutions, Inc. (MSS) 1575 Northside Drive. Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Jack Griffis Vice President, Research & Development (404) 249-9156 x11 (direct) (404) 249-9158 (fax) Jack.Griffis@MedShapeSolutions.com
- C. Device Information: WedgeLoc™ 180X Suture Anchor with Opti-Fiber™ Sutures Trade Name: Common Name: Suture Anchor
- Fastener, Fixation, Non-degradable, Soft Tissue Classification Name: D. HWC/MBI 21 CFR 888.3040 Suture, Nonabsorbable, Synthetic, Polyethylene GAT 21 CFR 878.500
- E. Predicate Device(s): MSS, WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture, K083792 Arthrex PushLock™ Suture Anchor, K051219 Arthrex FiberWIRE™ Polvblend Suture, K021434
- F. Labeling and Intended Use:
NOTE: Draft labels and instructions for use can be found in Attachment D. However, no changes to the labeling or Instructions for Use have been made to the original submitted information per K083792.
The proposed WedgeLoc™ 180X Suture Anchor and Opti-Fiber™ Suture has the same intended uses as the previously cleared device (K083792). 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:
1
1,091202 Lpg 212)
Special 510(k) Page L of 10
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Tenodesis. Acromio-Clavicular Separation Repair. Biceps Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
- Medial Collateral Ligament Repair, Lateral Collateral Ligament Knee: Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Collateral Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Ligament Ligament Reconstruction, Radial Collateral Reconstruction
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial collateral Ligament Reconstruction
- Substantial Equivalence Summary: G.
The proposed WedgeLoc™ 180X Suture Anchor is is substantially equivalent to the predicate WedgeLoc™ Suture Anchor with Opti-Fiber™ Suture (K08379) and the Arthrex PushLock™ Suture Anchor (K051219) in which the basic features and intended uses are the same. In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ Suture Anchors are equivalent. Any differences between the WedgeLoc™ 180X Suture Anchor and the predicate WedgeLoc™ or Arthrex PushLock™ Suture Anchors are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, MedShape Solutions, Inc. has determined that the new WedgeLoc™ 180X Suture Anchor is substantially equivalent to the currently marketed predicate device.
04/23/2009
Jack Griffes 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, black letters, with a line underneath it. Below the line, the word "SOLUTIONS" is written in smaller, black letters.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
SEP 1 6 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MedShape Solutions % Jack Griffis · 1575 Northside Drive. Suite 440 Atlanta, Georgia 30318
Re: K091202
Trade/Device Name: WedgeLoc™ 180x Suture Anchor and Opti-Fiber™ Sutures Regulation Number: 21 CFR 888.3040
Regulation Name: Smooth or threaded metallic bone fixation fastener
Regulatory Class: Class II
Product Code: HWC, MBI, GAT
Dated: September 2, 2009
Received: September 4, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Jack Griffis
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Boubeau Buchus
for
Mark N. Melk 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: K091202
Device Name: WedgeLoc™ 180X Suture Anchor and Opti-Fiber™ Sutures
Indications for Use:
The MedShape Solutions, Inc., WedgeLoc™ 180X 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, Achilles 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
Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Elbow: Ligament Reconstruction
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Onetu
(Division Sign-Off) for mxn
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091202