(150 days)
Not Found
No
The description focuses on the mechanical properties and function of a physical implant and inserter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "Implant Enhancement System" intended to "augment pedicle screw fixation" and "restore stability when the screw-to-bone interface becomes mechanically compromised," directly addressing a physical condition to improve patient health.
No
The device is described as an "Implant Enhancement System" intended to provide "supplemental fixation" to pedicle screw systems, restoring stability when a screw's purchase is lost. Its function is to mechanically secure a screw to bone. There is no mention of the device being used to identify, detect, or monitor a medical condition, disease, or its risk factors.
No
The device description explicitly details physical components (implant sleeve and inserter) made of materials like PET and stainless steel, and describes their mechanical function and insertion process. There is no mention of software as part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to augment pedicle screw fixation in the spine. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (sleeve) and an instrument (inserter) used during surgery. It is designed to provide mechanical support to a screw in bone.
- Lack of Diagnostic Purpose: The device does not perform any tests on biological samples (blood, urine, tissue, etc.) to diagnose a disease or condition. It is a therapeutic device used to improve the stability of a surgical implant.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) as a surgical implant.
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 implant of the Ogmend® Implant System consists of sterile, single-use devices intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The system includes a permanently implanted sleeve ("Ogmende Implant" or "Ogmend®" or "Sleeve") and an inserter ("Ogmend® Inserter Instrument" or "Inserter") to insert the Ogmend® Implant.
When inserted into a prepared bone hole, the Ogmend® Implant 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 and provides a helically braided structure that is captured by a screw when the screw is advanced during placement. Ogmend® has an inner diameter of 6.5mm and an outer diameter of 7.5mm, and can be used with screws ranging in diameter from 3.5mm. Ogmend® is supplied at a length of 100mm and is cut intra-operatively to the appropriate length.
The sole instrument used with the Ogmend® Implant System is the Inserter, which is used to insert the Sleeve into the hole. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves in a single 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
Pedicle (thoracolumbar)
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)
- Study type: Bench tests
- Cyclic Wear Testing with Particulate Testing per ASTM F1877
- Dynamic Compression Bending Strength per ASTM F1717
- Study type: Animal study
- Woven also performed an ovine study to further analyze the Ogmend® Implant according to biological and biomechanical metrics used to evaluate unique forces and movement placed on the screw-to-bone interface in the axial skeleton and in relation to commonly used spine fixation constructs (rods and screws).
- Study type: Clinical trial
- Woven performed a prospective, multicenter, non-controlled, clinical trial to evaluate the safety and performance of the Ogmend® Implant Enhancement System in subjects for the proposed indication.
- Key results: The clinical data revealed no screw loosening or backouts in screws augmented with the Ogmend® 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
§ 888.3043 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 27, 2023
Woven Orthopedic Technologies, LLC Mr. Brandon Bendes President 63 Center Street #3a Manchester, Connecticut 06040
Re: K223075
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: January 23, 2023 Received: January 24, 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 (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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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/5 description: The image contains the name "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. In the background, there is a faint watermark of the letters "FDA".
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
Enclosure
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Indications for Use
510(k) Number (if known) K223075
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY
MANUFACTURER IDENTIFICATION
Woven Orthopedic Technologies, LLC 63 Center Street #3a Manchester, CT USA 06040 Phone: 860-259-1260 Establishment Registration #3017505709 Contact Person: Brandon Bendes, President
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: | February 15, 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 implant of the Ogmend® Implant System consists of sterile, single-use devices intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The system includes a permanently implanted sleeve ("Ogmende Implant" or "Ogmend®" or "Sleeve") and an inserter ("Ogmend® Inserter Instrument" or "Inserter") to insert the Ogmend® Implant.
When inserted into a prepared bone hole, the Ogmend® Implant 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 and provides a helically braided structure that is captured by a screw when the screw is advanced during placement. Ogmend® has an inner diameter of 6.5mm and an outer diameter of 7.5mm, and can be used with screws ranging in diameter from 3.5mm. Ogmend® is supplied at a length of 100mm and is cut intra-operatively to the appropriate length.
4
The sole instrument used with the Ogmend® Implant System is the Inserter, which is used to insert the Sleeve into the hole. The Ogmend® Inserter is a stainless-steel rod with beveled ends. It can be used to insert multiple sleeves in a single 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 (DEN180065).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject Ogmend® Implant is identical to the primary predicate in material, design, principle of operation, implant size, sterilization method, inserter material and shelf life as detailed below:
| Implant Material: | Polyethylene Terephthalate |
|---|---|
| Implant Design: | Braided PET Sleeve Implant |
| Principle or Operation: | Enhance Screw / Bone Interface |
| Implant Size: | 6.5mm |
| Sterilization Method: | Gamma Irradiation |
| Inserter Material: | Stainless Steel |
| Shelf Life: | 36 Months |
PERFORMANCE DATA
The following bench tests were performed to support the substantial equivalence of the subject device in addition to the bench testing that was previously performed on the primary predicate in DEN180065:
- Cyclic Wear Testing with Particulate Testing per ASTM F1877
- Dynamic Compression Bending Strength per ASTM F1717 ●
Woven also performed an ovine study to further analyze the Ogmend® Implant according to biological and biomechanical metrics used to evaluate unique forces and movement placed on the screw-to-bone interface in the axial skeleton and in relation to commonly used spine fixation constructs (rods and screws).
In addition, Woven performed a prospective, multicenter, non-controlled, clinical trial to evaluate the safety and performance of the Ogmend® Implant Enhancement System in subjects for the proposed indication. The clinical data revealed no screw loosening or backouts in screws augmented with the Ogmend® device.
SUBSTANTIAL EQUIVALENCE
The clinical data, animal data, and bench testing data presented in this submission demonstrates that the proposed Ogmend® Implant Enhancement System is substantially equivalent to the primary predicate device with respect to intended use, technological characteristics, design, materials, principles of operation, and procedural steps.