(94 days)
Not Found
No
The summary describes a mechanical orthopedic implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is an orthopedic implant for fixing soft tissue to bone, not a therapeutic device that directly treats a condition or disease.
No
The device is an orthopedic implant for fixing soft tissue to bone, not for identifying or diagnosing medical conditions.
No
The device description clearly states it is a sterile, single-use orthopedic implant made of PEEK components, which are physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly state that the MedShape, Inc., ExoShape Duo Soft Tissue Fastener is an orthopedic implant used for fixation of soft tissue to bone within the body during surgical procedures. It is a physical device implanted into the patient, not a tool for analyzing biological samples outside the body.
The information provided focuses on the mechanical function and surgical application of the device, which is characteristic of a medical device used in vivo (within a living organism), not in vitro (in glass, referring to laboratory testing).
N/A
Intended Use / Indications for Use
The ExoShape® Duo 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, Tenodesis, Acromio-Clavicular Separation Repair. Biceps Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Lateral Foot/Ankle: Stabilization, Medial Stabilization, Achilles Tendon Repair. Hallux Valgus Reconstruction. Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction and Tendon Transfers
Knee: Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Reconstruction, Ligament Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The proposed ExoShape® Duo 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 ExoShape® Duo Soft Tissue Fastener is designed to use the principles of both interference fit and bearing area to reattach soft tissue intended for insertion into a hole created in bone,
The ExoShape® Duo Soft Tissue Fastener body is comprised of two interlocking PEEK. Both components are expanded into the bone hole. compressing the soft tissue against the bone wall and locking the implant to the bone; fastening the assembly 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
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)
Functional performance testing has been conducted in Sawbone® bone analoque. This testing included monotonic soft tissue fixation strength (pull-to-failure) 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 devices.
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.
MedShape, Inc., ExoShape® Soft Tissue Anchor, K101808 & K111471, MedShape, Inc., Eclipse™ Soft Tissue Fastener, K123350
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.
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Image /page/0/Picture/1 description: The image shows the logo for MedShape. The logo consists of a stylized letter "M" with a square on top and a circle on the bottom. To the right of the logo is the word "MEDSHAPE" in block letters. The logo is black and white.
Traditional 510(k) Page 10 of 91
510(k) Summary
Date Submitted: September 5, 2013
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(e).
- Submitter: A. MedShape. Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Stephen Laffoon Sr. Research & Development Engineer (678) 235-3324 (direct) (404) 249-9158 (fax) stephen.laffoon@medshape.com
- ். Device Information: ExoShape® Duo Soft Tissue Fastener Trade Name(s):
Common Name(s): Fastener, Fixation, bone
- D. Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue HWC/MBI 21 CFR 888.3040
E. Predicate Device(s): MedShape, Inc., ExoShape® Soft Tissue Anchor, K101808 & K111471 MedShape, Inc., Eclipse™ Soft Tissue Fastener, K123350
L Physical Description:
The proposed ExoShape® Duo 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 ExoShape® Duo Soft Tissue Fastener is designed to use the principles of both interference fit and bearing area to reattach soft tissue intended for insertion into a hole created in bone,
The ExoShape® Duo Soft Tissue Fastener body is comprised of two interlocking PEEK. Both components are expanded into the bone hole. compressing the soft tissue against the bone wall and locking the implant to the bone; fastening the assembly into place.
- G. Indications for Use:
The ExoShape® Duo 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:
1575 Northside Drive, Suite 440, Atlanta, GA 30318 678-235-3311 phone 404-249-9158 fax
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K132783 (2/2)
Traditional 510(k) Page 11 of 91
- Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Tenodesis, Acromio-Clavicular Separation Repair. Biceps Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Stabilization, Medial Stabilization, Achilles Tendon Lateral Foot/Ankle: Repair. Hallux Valgus Reconstruction. Mid-foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction and Tendon Transfers
- Cruciate Ligament Repair, Medial Collateral Ligament Repair, Knee: Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment and Ulnar or Radial collateral Elbow: Ligament Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Reconstruction, Ligament Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and Repairs and Tendon Transfers
- H. Comparison of Technological Characteristics: The ExoShape® Duo Soft Tissue Fastener is substantially equivalent in function and intended use to the following predicate devices:
MedShape, Inc., ExoShape® Soft Tissue Anchor, K101808 & K111471 MedShape, Inc., Eclipse™ Soft Tissue Fastener, K123350
All fasteners are comprised of implant grade PEEK. All fasteners have the same indications for use. In addition, functional performance testing has been conducted in Sawbone® bone analoque. This testing included monotonic soft tissue fixation strength (pull-to-failure) 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 devices.
9/9/13
Stephen Laffoon Sr. Research & Development Engineer
Image /page/1/Picture/12 description: The image shows the logo for Medshape. The logo consists of a stylized letter "a" with a square on top, followed by the word "MEDSHAPE" in block letters. The logo is in black and white.
1575 Northside Drive, Suite 440 Atlanta, GA 30318 877-343-7016 phone 404-249-9158 fax
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-like symbol with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 9, 2013
MedShape, Incorporated Mr. Stephen Laffoon Senior Research & Development Engineer 1575 Northside Drive Northwest, Suite 440 Atlanta, Georgia 30318
Re: K132783
Trade/Device Name: ExoShape® Duo Soft Tissue Fastener Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: September 5, 2013 Received: September 12, 2013
Dear Mr. Laffoon:
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. Stephen Laffoon
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use :
510(k) Number: _K132783
Device Name: ExoShape® Duo Soft Tissue Fastener
Indications for Use:
The MedShape, Inc., ExoShape Duo Soft Tissue Fastener is intended for fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist and elbowing 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 Achilles Tendon Reconstruction and Tendon Transfers
- Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Knee: Collateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
- Biceps Tendon Reattachment and Ulnar or Radial collateral Ligament Elbow. Reconstruction
- 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
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)
Casey L. Hanley, Ph.D.
Page 1 of 1
Division of Orthopedic Devices