(28 days)
Not Found
No
The summary describes a mechanical implant and inserter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests focused on mechanical properties.
No.
The device is intended to augment pedicle screw fixation and provide supplemental fixation to restore stability, which falls under structural support rather than a direct therapeutic effect on a disease or condition.
No.
The device is described as an implant enhancement system for surgical use, intended to provide supplemental fixation and restore stability, not to diagnose a condition.
No
The device description clearly states that the system includes a permanently implanted sleeve and an inserter, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Ogmend® Implant Enhancement System is a physical implant and insertion tool designed to augment pedicle screw fixation in the spine. It is surgically implanted into the bone.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples, nor does it provide diagnostic information about a patient's condition. Its function is purely mechanical and structural.
Therefore, the Ogmend® Implant Enhancement System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.
Product codes
QVI
Device Description
The Ogmend® Implant Enhancement System is a sterile, single-use device intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant Enhancement System includes a permanently implanted sleeve ("Ogmend® Implant") and an inserter ("Ogmend® Inserter").
The Ogmend® Implant Enhancement System is designed to use the principles of interference fit, surface area contact, and pressure distribution to secure a screw to bone and achieve stability at the screw-to-bone interface to allow for subsequent healing.
The Ogmend® Implant is manufactured from polyethylene terephthalate (PET) monofilament fibers.
The Ogmend® Implant is offered in two sizes:
- Medium: For use with screws ranging in diameter from 3.5mm - 6.5mm.
- Large: For use with screws ranging in diameter from 6.5mm 10.5mm. ●
The Ogmend® Inserter is used to insert the Ogmend® Implant into the bone hole and can be used with both size Ogmend® Implants. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves within one operative procedure. It is provided sterile as a disposable, single-use device. The Inserter is compatible with sterilization by gamma radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar pedicle, vertebral body
Indicated Patient Age Range
skeletally mature patients
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)
The bench tests listed below were performed to support the substantial equivalence of the subject device in addition to the bench tests were previously purposed on the primary predicate in K223075:
- Screw Axial Pullout
- Sleeve Insertion Force
- Screw Insertion Torque
- Screw Removal/Extraction Torque
- Sleeve End Closure Strength
- Device Breakage- Sleeve Durability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ogmend® Implant Enhancement System (K223075)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3043 Screw sleeve bone fixation device.
(a)
Identification. A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone and provides increased surface area to create an interference fit to restore stability of the implant construct.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo performance testing under anticipated conditions of use must demonstrate:
(i) The device provides sufficient stability to allow for fracture healing; and
(ii) A lack of adverse biologic response to the implant through histopathological and histomorphometric assessment.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must:
(i) Assess the stability of the device in a rescue screw scenario;
(ii) Demonstrate that the device can be inserted and removed without damage to the implant or associated hardware;
(iii) Demonstrate the device can withstand dynamic loading without device failure; and
(iv) Characterize wear particle generation.
(3) The device must be demonstrated to be biocompatible.
(4) The device must be demonstrated to be non-pyrogenic.
(5) Performance data must demonstrate the sterility of the device.
(6) Performance data must support the labeled shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the established shelf life.
(7) Labeling must include:
(i) A detailed summary of the device technical parameters;
(ii) Information describing all materials of the device;
(iii) Instructions for use, including device removal; and
(iv) A shelf life.
0
October 26, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
Woven Orthopedic Technologies Mr. Brandon Bendes President and CEO 63 Center Street, #3a Manchester, Connecticut 06040
Re: K233223
Trade/Device Name: Ogmend® Implant Enhancement System Regulation Number: 21 CFR 888.3043 Regulation Name: Screw Sleeve Bone Fixation Device Regulatory Class: Class II Product Code: QVI Dated: September 28, 2023 Received: September 28, 2023
Dear Mr. Bendes:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image contains the text "Colin O'neill -S-". The text is arranged vertically, with "Colin" on the top line, "O'neill" on the second line, and "-S-" on the third line. The text is in a simple, sans-serif font and is black in color. The background of the image is white.
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health 2
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
= $98$$%
Device Name
Ogmend® Implant Enhancement System
Indications for Use (Describe)
The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
3
510K Summary
MANUFACTURER IDENTIFICATION
Woven Orthopedic Technologies 63 Center Street #3a, Manchester, CT 06040 Phone: 860-259-1260 Establishment Registration #3017505709 Contact Person: Brandon Bendes, President and CEO
DEVICE IDENTIFICATION
| Device Trade Name: | Ogmend® Implant Enhancement System |
|---|---|
| Device Common Name: | Screw Sleeve Bone Fixation Device |
| Classification Name: | Screw Sleeve Bone Fixation Device |
| Classification Number: | 21 CFR 888.3043 |
| Product Code: | QVI |
| Device Class: | Class II |
| Review Panel: | Orthopedic Devices |
| Date Summary Prepared: | September 28, 2023 |
INDICATIONS FOR USE
The Ogmend® Implant Enhancement System is intended to augment pedicle screw fixation when a screw has lost purchase due to screw loosening, back-out, or breakage. The Ogmend® Implant Enhancement System is for use with rigid, thoracolumbar pedicle screw systems where a screw is inserted posteriorly, through the pedicle, and into the vertebral body. The Ogmend® Implant Enhancement System is for use in skeletally mature patients.
DEVICE DESCRIPTION
The Ogmend® Implant Enhancement System is a sterile, single-use device intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant Enhancement System includes a permanently implanted sleeve ("Ogmend® Implant") and an inserter ("Ogmend® Inserter").
The Ogmend® Implant Enhancement System is designed to use the principles of interference fit, surface area contact, and pressure distribution to secure a screw to bone and achieve stability at the screw-to-bone interface to allow for subsequent healing.
The Ogmend® Implant is manufactured from polyethylene terephthalate (PET) monofilament fibers.
The Ogmend® Implant is offered in two sizes:
- Medium: For use with screws ranging in diameter from 3.5mm - 6.5mm.
- Large: For use with screws ranging in diameter from 6.5mm 10.5mm. ●
4
K233223 - Page 2 of 3
The Ogmend® Inserter is used to insert the Ogmend® Implant into the bone hole and can be used with both size Ogmend® Implants. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves within one operative procedure. It is provided sterile as a disposable, single-use device. The Inserter is compatible with sterilization by gamma radiation.
PRIMARY PREDICATE DEVICE
Ogmend® Implant Enhancement System (K223075).
Comparison of Technological Characteristics to Predicate
The subject Ogmend® Implant is identical to the primary predicate with respect to materials, design, principle of operation, sterilization method, inserter material, and shelf life as detailed below. The subject and predicate devices are also identical with respect to Intended Use and Indications for use.
| Implant Material: | Polyethylene Terephthalate |
|---|---|
| Implant Design: | Braided PET Sleeve Implant |
| Principle or Operation: | Enhance Screw / Bone Interface |
| Sterilization Method: | Gamma Irradiation |
| Inserter Material: | Stainless Steel |
| Shelf Life: | 36 Months |
The distinguishing characteristics between the subject and predicate devices are detailed below:
| Technological
Characteristic | Medium Ogmend® Implant
(K223075) | Large Ogmend® Implant
(proposed) |
|----------------------------------------|-------------------------------------|-------------------------------------|
| Sleeve Diameter | 6.5mm | 8.5mm |
| Sleeve Length | 100mm | 150mm |
| Compatible
Pedicle Screw Size Range | 3.5mm - 6.5mm | 6.5mm - 10.5mm |
PERFORMANCE DATA
The bench tests listed below were performed to support the substantial equivalence of the subject device in addition to the bench tests were previously purposed on the primary predicate in K223075:
| # | Performance Test |
|---|---|
| 1 | Screw Axial Pullout |
| 2 | Sleeve Insertion Force |
| 3 | Screw Insertion Torque |
| 4 | Screw Removal/Extraction Torque |
| 5 | Sleeve End Closure Strength |
| 6 | Device Breakage- Sleeve Durability |
Woven Orthopedic Technologies, LLC | 63 E. Center Street, Manchester CT USA 06040 | +1 860.259.1260
5
K233223 - Page 3 of 3
SUBSTANTIAL EQUIVALENT
The data presented in this submission demonstrates that the proposed Ogmend® Implant is substantially to intended use, technological characteristics, design, materials, principles of operation, and procedural steps, the pre-determined acceptance criteria, performance with respect to intended use.
Woven Orthopedic Technologies, LLC | 63 E. Center Street, Manchester CT USA 06040 | +1 860.259.1260