(132 days)
Not Found
No
The 510(k) summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is an orthopedic implant intended for fixation of soft tissue to bone in various reconstructive and repair procedures, which directly addresses medical conditions and injuries.
No
The MedShape Solutions, Inc., ShapeLoc™ Soft Tissue Fastener is an orthopedic implant designed for fixation of soft tissue to bone during surgical procedures. It is a treatment device, not one used for diagnosis.
No
The device description clearly states it is a sterile, single-use orthopedic implant comprised of physical components (PEEK sleeve and insert) intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "sterile, single use, orthopedic implant" that uses "interference fit to reattached soft tissue intended for attachment into a hole created in bone." This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health, diagnosis, or condition.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to repair tissue within the body.
N/A
Intended Use / Indications for Use
The MedShape Solutions, Inc., ShapeLoc™ Soft Tissue Fastener is intended for fixation of 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 or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
- Knee: Cruciate Ligament Repair, 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. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
- Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI
Device Description
The proposed ShapeLoc™ Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The ShapeLoc™ Soft Tissue Fastener is designed to use the principles of interference fit to reattached soft tissue intended for attachment into a hole created in bone. The ShapeLoc™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue against the bone wall; fastening it into place.
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 and elbow
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)
Functional performance testing has been conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength (pull-to-failure), dynamic loosening testing for the deployed assembly and other dimensional verification and material safety testing (both bio and MRI compatibility). Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate device.
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
Image /page/0/Picture/0 description: The image shows the logo for MEDSHAPE SOLUTIONS. The words "MEDSHAPE" are in large, bold, sans-serif font, with a line underneath. Below the line, the word "SOLUTIONS" is in a smaller, sans-serif font.
510(k) Page _ of 2
510(k) Summary
NOV - 8 2010
510(k) Number: K101808
October 28th, 2010 Date Revised:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- A. Submitter: MedShape Solutions, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Jack Griffis Vice President, Research & Development (404) 249-9155 x11 (direct) (404) 249-9158 (fax) Jack.Griffis@MedShape.com
- C. Device Information: ShapeLoc™ Fastener Trade Name: Common Name: Fastener, Fixation, bone, non-degradable
- D. Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue HWC/MBI 21 CFR 888.3040
- E. Predicate Device(s): Arthrex Interference Screw, K062466
F. Physical Description:
The proposed ShapeLoc™ Soft Tissue Fastener is a sterile, single use, orthopedic implant intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon bone. The ShapeLoc™ Soft Tissue Fastener is designed to use the principles of interference fit to reattached soft tissue intended for attachment into a hole created in bone. The ShapeLoc™ Soft Tissue Fastener body is comprised of an implant grade PEEK sleeve and implant grade PEEK insert. The outer sleeve is expanded into the bone hole, compressing the soft tissue against the bone wall; fastening it into place.
- G. Indications for Use:
The ShapeLoc™ Soft Tissue Fastener is indicated for fixation of 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 or Capsulolabral Reconstruction
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- Lateral Stabilization, Medial Stabilization, Achilles Tendon Foot/Ankle: Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
- Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Reconstruction, Ulnar Collateral Hand/Wrist: Scapholunate Ligament Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
- Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
- H. Comparison of Technological Characteristics:
The ShapeLoc™ Soft Tissue Fastener is substantially equivalent in function and intended use to the following predicate device:
Arthrex Interference Screw, K062466
Both fasteners are comprised of implant grade PEEK. Both fasteners have the same indications for use. In addition, functional performance testing has been conducted in both Sawbone® and porcine bone analogues. This testing included monotonic soft tissue fixation strength (pull-to-failure), dynamic loosening testing for the deployed assembly and other dimensional verification and material safety testing (both bio and MRI compatibility). Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate device.
Jack Griffis
Jack Griffis Vice President, Research & Development
Image /page/1/Picture/11 description: The image shows the word "MEDSHAPE" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. A horizontal line is placed directly underneath the word, spanning its entire length.
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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 with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
MedShape Solutions. Inc. % Mr. Jack Griffis 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
NOV - 8 2010
Re: K101808 Trade/Device Name: ShapeLoc Fastener Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: October 28, 2010 Received: October 29, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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.fda.gov/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,
Mark N. Melkerson Director Division of Surgical, Orthopedic . and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: KID| 808
NOV - 8 2010
Device Name: ShapeLoc™ Soft Tissue Fastener
Indications for Use:
The MedShape Solutions, Inc., ShapeLoc™ Soft Tissue Fastener is intended for fixation of 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 or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Foot/Ankle: Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Anchiles Tendon Reconstruction and Tendon Transfers
- Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Scapholunate Ligament Hand/Wrist: Reconstruction, Ulnar Collateral Ligament Reconstruction. Collateral Radial Ligament Reconstruction. Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
- Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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) mitte mxm (Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101808
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