(92 days)
Not Found
No
The description focuses on the mechanical components and materials of a bone anchor, with no mention of AI or ML capabilities.
No.
The device is described as an implantable bone anchor used for fixation of suture to bone, intended for orthopedic reconstruction and repair, not for treating diseases or conditions in a therapeutic manner.
No
Explanation: The device is a bone anchor used for surgical fixation of sutures to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components made of titanium, PET, and UHMWPE, and mentions a disposable delivery tool and bone awl, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of suture to bone in specific anatomical locations (Foot/Ankle, Hand/Wrist). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (bone anchor) and associated delivery tools. It is not designed to analyze samples taken from the human body (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications:
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Product codes
MBI
Device Description
The Rimclose Bone Anchor consists of one (1) bone anchor assembly, pre-loaded on a disposable delivery tool. The Bone Anchor is packaged with a disposable Bone Awl to facilitate placement of the device. The device is provided in one size only.
The bone anchor assembly is comprised of one (1) titanium (Ti-6Al-4V ELI) toggle-anchor, connected to an adjustable polyethylene terephthalate (PET) 2-0 braided suture loop, via an intermittent length of size 0 ultra high molecular weight polyethylene (UHMWPE) Force Fiber suture.
The device's titanium component conforms to ASTM F-136. The device's polyethylene terephthalate (PET) and ultra high molecular weight polyethylene (UHMWPE) suture components conform to USP requirements. The constructs are provided sterile and preloaded on disposable delivery instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot/Ankle, Hand/Wrist
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
Biocompatibility and bench testing were completed and support the safety and effectiveness of the Rimclose Bone Anchor. The bone anchors demonstrated equivalent fixation strength which greatly exceeded the tensile strength of the suture. USP performance characteristics serve as a guide in matching suture to procedural applications.
Key Metrics
Not Found
Predicate Device(s)
Arthrex Small Bone FASTak™ Suture Anchor (K971723)
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.
0
K082729 1/2
Section 5 - 510(k) Summary
| Submitter: | Anulex Technologies, Inc.
5600 Rowland Road, Suite 280
Minnetonka, MN 55343 | DEC 19 2008 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Rachel Kennedy
Senior Regulatory Affairs Manager
Anulex Technologies, Inc.
Direct: 952.224.4034
Fax: 952.224.4040
E-Mail: rkennedy@anulex.com | |
| Date Prepared: | September 15, 2008 | |
| Trade Name: | Rimclose Bone Anchor | |
| Classification: | II | |
| Product Code: | MBI
21 CFR 888.3040 | |
| Predicate Device(s): | The subject device is substantially equivalent to the following
predicate device:
• Arthrex Small Bone FASTak™ Suture Anchor
(K971723 cleared July 30, 1997) | |
| Device Description: | The Rimclose Bone Anchor consists of one (1) bone anchor
assembly, pre-loaded on a disposable delivery tool. The Bone
Anchor is packaged with a disposable Bone Awl to facilitate
placement of the device. The device is provided in one size
only.
The bone anchor assembly is comprised of one (1) titanium (Ti-
6Al-4V ELI) toggle-anchor, connected to an adjustable
polyethylene terephthalate (PET) 2-0 braided suture loop, via an
intermittent length of size 0 ultra high molecular weight
polyethylene (UHMWPE) Force Fiber suture.
The device's titanium component conforms to ASTM F-136.
The device's polyethylene terephthalate (PET) and ultra high
molecular weight polyethylene (UHMWPE) suture components
conform to USP requirements. The constructs are provided
sterile and preloaded on disposable delivery instruments. | |
| Indications for Use: | The Rimclose Bone Anchor is intended for fixation of suture to
bone. This product is intended for the following indications: | |
| | Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles
Tendon Repair, Hallux Valgus Reconstruction, Midfoot
Reconstruction, Metatarsal Ligament Repair | |
| | Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar
Collateral Ligament Reconstruction, Radial Collateral Ligament
Reconstruction | |
| Functional and
Safety Testing: | Biocompatibility and bench testing were completed and support
the safety and effectiveness of the Rimclose Bone Anchor. | |
| Conclusion: | The Rimclose Bone Anchor is substantially equivalent to the
Arthrex FASTak Suture Anchor (7.5mm). In this case,
substantial equivalence is based on having the same intended use
with minor differences in technological characteristics, such that
it can be demonstrated that the device is as safe and effective as
the predicate device. Both anchors are both made of titanium.
FASTak uses threads for fixation in bone while the Rimclose
anchor is a T-anchor which toggles on deployment. Both
anchors are provided with suture to facilitate attachment to soft
tissue. The bone anchors demonstrated equivalent fixation
strength which greatly exceeded the tensile strength of the
suture. USP performance characteristics serve as a guide in
matching suture to procedural applications. | |
1
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Anulex Technologies, Inc. % Ms. Rachel Kennedy Senior Regulatory Affairs Manager 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
DEC 1 9 2008
Re: K082729 Trade/Device Name: Rimclose Bone Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 18, 2008 Received: December 19, 2008
Dear Ms. Kennedy:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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.
3
Page 2 - Ms. Rachel Kennedy
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Mulkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Statement
Device Name: Rimclose Bone Anchor
Indications for Use:
The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications:
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David Krome for MXM 12/09/2005
Division of General, Restorative, and Neurological Devices
510(k) Number K082729
Rimclose Bone Anchor Anulex Technologies, Inc. K082729
Traditional 510(k) Premarket Notification