(94 days)
No
The summary describes a mechanical surgical implant and delivery system, with no mention of software, data processing, or AI/ML terms.
No
The device is an all-inside meniscal repair system used for anchoring allograft to the meniscal rim during transplant procedures. It is a surgical implant designed for mechanical repair, not a device that directly treats or cures a disease or condition with therapeutic effect.
No
The device is described as an "all-inside meniscal repair system" intended for "meniscal repairs and meniscal allograft transplant procedures." Its function is to anchor allografts and provide fixation, which are treatment functions, not diagnostic ones.
No
The device description clearly states the device is an "all-inside meniscal repair system" consisting of physical implants (rigid backstops, suture, and braid) and an applier. This is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "meniscal repairs and meniscal allograft transplant procedures" and "anchoring the allograft to the meniscal rim". This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as an "all-inside meniscal repair system" consisting of implants (backstops, suture, braid) and an applier. This is a physical device used in surgery.
- Anatomical Site: The anatomical site is the "meniscal rim", which is part of the knee joint.
- Performance Studies: The performance studies focus on "Implant system strength" and "Biocompatibility", which are relevant to a surgical implant.
In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
N/A
Intended Use / Indications for Use
The TRUESPAN Meniscal Repair System is intended for use in meniscal repairs and meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for anchoring the allograft to the meniscal rim during allograft transplant procedures.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The proposed device is an all-inside meniscal repair system. The implant consists of two rigid backstops (absorbable PLGA1 or non-absorbable PEEK2), size #2-0 Orthocord suture and UHMWPE braid. The implant system and applier are pre-assembled, and the whole device is sterile, for single patient use only. Compression of the fixation point is accomplished by pulling on the suture post to allow the two suture strands creating the bridge between the implants to lay tight on the surface of the fixation point. *1 PLGA: Poly(lactide-co-glycolide) *2 PEEK: polyaryletherketone
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
meniscal / meniscal rim
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)
Implant system strength was evaluated in vitro and after cyclic (bench top). The testing demonstrated substantial equivalence of performance to the predicate device. Biocompatibility is also confirmed based on biocompatibility data and justification. The proposed device has raised no new issue of safety and efficacy.
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.
Fast-Fix 360 Meniscal Repair System (K121861, K092508; Smith & Nephew)
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.
Ultra Fast-Fix Meniscal Repair System (K121861, K072322; Smith & Nephew), Omnispan Meniscal Repair System (K092836, DePuy Mitek)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2016
Medos International SARL % Yayoi Fujimaki Regulatory Affairs Senior Associate Depuy Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K153667
Trade/Device Name: TRUESPAN™ Meniscal Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 17, 2016 Received: February 18, 2016
Dear Yayoi Fujimaki:
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 Parts 801); medical device 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/ResourcesforYou/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 yours,
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
510(k) Number (if known)
Device Name
Truespan Meniscal Repair System
Indications for Use (Describe)
The TRUESPAN Meniscal Repair System is intended for use in meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair System is intended to be used for the meniscal rim during allograft transplant procedures.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image shows the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The logo features a geometric design to the left of the company name, "DePuy Synthes," which is in a bold, dark blue font. Below that, "MITEK SPORTS MEDICINE" is written in a smaller, lighter blue font. Underneath the company name is the text "COMPANIES OF" followed by the Johnson & Johnson logo in red.
510(k) SUMMARY TRUESPAN™ Meniscal Repair System
| Date Summary
| Prepared | December 18, 2015 | |
|---|---|---|
| Submitter's | ||
| Name and | ||
| Address | DePuy Mitek | |
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767 | ||
| Manufacturer | Medos International SARL | |
| Chemin-Blanc 38, Le Locle Neuchatel | ||
| CH 2400, Switzerland | ||
| Contact Person | Yayoi Fujimaki | |
| Regulatory Affairs Senior Associate | ||
| DePuy Mitek | ||
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham, MA 02767, USA | Telephone: 508-828-3541 | |
| Facsimile: 508-977-6911 | ||
| e-mail: yfujima1@its.jnj.com | ||
| Name of | ||
| Medical Device | Trade Name: TRUESPANTM Meniscal Repair System | |
| Common Name: Fastener, fixation, degradable, soft tissue | ||
| Device | ||
| Classification | MBI - Smooth or threaded metallic bone fixation fastener, classified as Class II, regulated per 21 CFR 888.3040. Orthopedic panel | |
| Predicate | ||
| Device | Predicate: Fast-Fix 360 Meniscal Repair System (K121861, K092508; Smith & Nephew) Reference: Ultra Fast-Fix Meniscal Repair System (K121861, K072322; Smith & Nephew) Reference: Omnispan Meniscal Repair System (K092836, DePuy Mitek) | |
| Indications for | ||
| Use | The TRUESPAN Meniscal Repair System is intended for use in meniscal repairs | |
| and meniscal allograft transplant procedures. The TRUESPAN Meniscal Repair | ||
| System is intended to be used for anchoring the allograft to the meniscal rim | ||
| during allograft transplant procedures. | ||
| Device | ||
| Description | The proposed device is an all-inside meniscal repair system. The implant | |
| consists of two rigid backstops (absorbable PLGA1 or non-absorbable PEEK2), | ||
| size #2-0 Orthocord suture and UHMWPE braid. The implant system and | ||
| applier are pre-assembled, and the whole device is sterile, for single patient use | ||
| only. Compression of the fixation point is accomplished by pulling on the suture | ||
| post to allow the two suture strands creating the bridge between the implants to | ||
| lay tight on the surface of the fixation point. | ||
| *1 PLGA: Poly(lactide-co-glycolide) | ||
| *2 PEEK: polyaryletherketone | ||
| Safety and | ||
| Performance | Implant system strength was evaluated in vitro and after cyclic (bench top). The | |
| testing demonstrated substantial equivalence of performance to the predicate | ||
| device. Biocompatibility is also confirmed based on biocompatibility data and | ||
| justification. The proposed device has raised no new issue of safety and efficacy. | ||
| Substantial | ||
| Equivalence | The proposed device is an all-inside meniscal repair system. The proposed | |
| device consists of two rigid backstops and sutures. The technological | ||
| characteristics are similar to the predicate device. Implant system strength | ||
| demonstrated substantial equivalency of performance. Differences found | ||
| between the proposed and the predicate device are considered minor and do not | ||
| raise questions concerning safety and efficacy. The proposed device is | ||
| determined substantially equivalent to the predicate device. |
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Image /page/5/Picture/0 description: The image contains the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The logo features a geometric design to the left of the text "DePuy Synthes" in a dark blue sans-serif font. Below this, "MITEK SPORTS MEDICINE" is written in a smaller, similar font. Underneath a thin line, the text "COMPANIES OF" appears above the Johnson & Johnson logo.