(133 days)
No
The summary describes a physical orthopedic implant (a bone anchor) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is an orthopedic implant for soft tissue to bone reattachment, which is a structural repair, not a therapeutic treatment.
No
The device is an orthopedic implant for soft tissue to bone reattachment, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a sterile, single-use orthopedic implant comprised of PEEK and pre-loaded on a disposable driver handle, indicating it is a physical hardware device.
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 for reattaching soft tissue to bone in various anatomical locations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a sterile, single-use orthopedic implant made of PEEK, pre-loaded on a driver handle. This aligns with the description of a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis or monitoring a disease state.
- Performance Studies: The performance studies focus on mechanical strength, dimensional verification, and material safety – all relevant to a surgical implant's function and safety, not diagnostic accuracy.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's purpose is to physically fix tissue during surgery.
N/A
Intended Use / Indications for Use
The MedShape PEEK Interference Screw is intended for soft tissue to bone reattachment in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically;
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 Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament 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, Tendon Transfer in the Hand/Wrist
Product codes
HWC, MBI
Device Description
The proposed Helical Ridge Bone Anchor is a sterile, single use, orthopedic implant intended to be used for fixation of soft tissue to bone.
The Helical Ridge Bone Anchor is comprised of PEEK. The anchor is provided sterile and pre-loaded on a disposable driver handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, elbow, foot/ankle, knee, and hand/wrist
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)
Functional performance testing to confirm substantial equivalence as follows:
- Monotonic soft tissue fixation strength in Sawbone bone analogue
- Dimensional verification testing for product samples
- Material safety testing (both biocompatibility 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)
MedShape, Inc., Morphix® Suture Anchor, K091202, MedShape, Inc., Eclipse Soft Tissue Fastener, K123350, Arthrex SwiveLock® Bone Anchor, K101823, Arthrex Tenodesis Product Family, K051726
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 29, 2014
MedShape, Incorporated Mr. Jack Griffis Vice President, Research & Development 1575 Northside Drive NW, Suite 440 Atlanta, Georgia, 30318
Re: K141290
Trade/Device Name: Helical Ridge Bone Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: August 27, 2014 Received: August 29, 2014
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
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K141290 510(k) Number:
Device Name: Helical Ridge Bone Anchor
Indications for Use:
The MedShape PEEK Interference Screw is intended for soft tissue to bone reattachment in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically;
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 Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Scapholunate Ligament Reconstruction, Ulnar Hand/Wrist: Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint Arthroplasty (Basal Thumb Joint Arthroplasty), Carpal Ligament Reconstructions and Repairs, Tendon Transfer in the Hand/Wrist
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)
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Image /page/3/Picture/0 description: The image shows the MedShape logo. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape is a combination of a circle and a square. The word "MEDSHAPE" is in a sans-serif font.
510(k) Summary
September 22nd, 2014 Date Submitted:
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(e).
- A. Submitter: MedShape. Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
- B. Company Contact: Jack Griffis VP, Research & Development (678) 235-3311 (direct) (404) 249-9158 (fax) jack.griffis@medshape.com
| C. | Device Information: | |
|---|---|---|
| Trade Name(s): | Helical Ridge Bone Anchor | |
| MedShape PEEK Interference Screw |
Common Name(s): Fastener, Fixation, Bone
- D. Classification Name: Fastener, Fixation, Non-degradable, Soft Tissue HWC/MBI 21 CFR 888.3040
- ட். Predicate Device(s): MedShape, Inc., Morphix® Suture Anchor, K091202 MedShape, Inc., Eclipse Soft Tissue Fastener, K123350 Arthrex SwiveLock® Bone Anchor, K101823 Arthrex Tenodesis Product Family, K051726
ட Physical Description: The proposed Helical Ridge Bone Anchor is a sterile, single use, orthopedic implant intended to be used for fixation of soft tissue to bone.
The Helical Ridge Bone Anchor is comprised of PEEK. The anchor is provided sterile and pre-loaded on a disposable driver handle.
- G. Indications for Use:
The MedShape PEEK Interference Screw is intended for soft tissue to bone reattachment in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically;
4
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 Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament 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, Tendon Transfer in the Hand/Wrist
- H. Comparison of Technological Characteristics:
The Helical Ridge Bone Anchor is substantially equivalent in function and intended use to the following predicate devices:
MedShape, Inc., Morphix® Suture Anchor, K091202 MedShape, Inc., Eclipse Soft Tissue Fastener, K123350 Arthrex SwiveLock® Bone Anchor, K101823 Arthrex Tenodesis Product Family, K051726
All anchors are comprised of implant grade PEEK. All anchors have the same indications for use. In addition, functional performance testing to confirm substantial equivalence as follows:
- Monotonic soft tissue fixation strength in Sawbone® bone analogue ●
- Dimensional verification testing for product samples ●
- . Material safety testing (both biocompatibility and MRI compatibility).
Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices.
Jack Griffis VP, Research & Development
Image /page/4/Picture/15 description: The image shows the logo for MedShape. The logo consists of a blue abstract shape on the left and the word "MEDSHAPE" in gray on the right. The abstract shape appears to be a combination of a circle and a square.
1575 Northside Drive, Suite 440 Atlanta, GA 30318 877-343-7016 phone 404-249-9158 fax