(101 days)
Not Found
No
The document describes a mechanical implant system (nails, screws, end cap) for ankle fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance study is an engineering analysis of bending strength, not an evaluation of algorithmic performance.
No.
The device is an implantable nail system used for fixation and arthrodesis of long bones, addressing structural and orthopedic issues rather than delivering a therapeutic substance or direct therapeutic effect in the way a drug or radiation therapy would.
No
The device is an implantable system (nails, screws, and end cap) designed for the fixation of bones to correct deformity or facilitate arthrodesis, not for diagnosing conditions.
No
The device description clearly states it consists of physical components (nails, screws, end cap) made of titanium, which are implanted into the body. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The Ascension® Ankle Fusion Nail System is a surgical implant made of titanium. It is inserted into bones to fix fractures, correct deformities, or perform arthrodesis (joint fusion).
- Intended Use: The intended uses listed are all related to treating musculoskeletal conditions and injuries through surgical intervention and implantation.
The device is a surgical implant used in vivo (within the body) for structural support and fixation, not for analyzing biological samples in vitro (outside the body).
N/A
Intended Use / Indications for Use
The Ascension® Ankle Fusion Nail System is intended for the following:
- . Charcot Foot
- Avascular necrosis of the talus .
- Failed total ankle arthroplasty .
- . Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular . accident, paralysis or other neuromuscular disease
- . Revision ankle arthrodesis
- . Neuroarthropathy
- . Rheumatoid arthritis
- Osteoarthritis .
- Pseudoarthrosis .
- Post-Traumatic arthrosis .
- Previously infected arthrosis .
- Severe end stage degenerative arthritis t
- Severe defects after tumor resection .
- Pantalar arthrodesis .
Product codes
HSB
Device Description
The Ascension® Ankle Fusion Nail System is to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared for correction of deformity, or arthodesis.
The Ankle Fusion Nail System consists of nails, screws and an end cap. The standard nails are offered in three diameters and 3 lengths (150mm, 180mm and 210mm). Longer lengths up to 460mm will be made upon request. Fixation screws consist of one diameter and 27 lengths, and an end cap offered in one size. All three implant components will be manufactured from titanium 6AL-4V.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
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
An engineering analysis was completed on the proposed device and the predicate devices. Results demonstrate equivalence in bending strength to the legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
2010
510(k) Summary
| SUBMITTER NAME: | Ascension Orthopedics, Inc.
8700 Cameron Road, #100
Austin, TX 78754-3832 |
|-----------------|---------------------------------------------------------------------------------|
| 510(k) CONTACT: | Stan Harris
Phone: (512) 836-5001 x1585 |
| TRADE NAME: | Ascension® Ankle Fusion Nail System |
| COMMON NAME: | Titanium Intramedullary Nail (Rod) |
| CLASSIFICATION: | 21 CFR 888.3020 - Rod, Fixation, Intramedullary And
Accessories |
| PRODUCT CODE: | HSB |
| PANEL: | Orthopedic |
PREDICATE DEVICES:
K091976 - Biomet Ankle Arthrodesis Nail, Biomet Phoenix Ankle Nail System K051590 - Stryker T2 Ankle Arthrodesis Nail
DEVICE DESCRIPTION:
The Ascension® Ankle Fusion Nail System is to be implanted by insertion into the long bones for fixation of fractures, or the fixation of long bones that have been surgically prepared for correction of deformity, or arthodesis.
The Ankle Fusion Nail System consists of nails, screws and an end cap. The standard nails are offered in three diameters and 3 lengths (150mm, 180mm and 210mm). Longer lengths up to 460mm will be made upon request. Fixation screws consist of one diameter and 27 lengths, and an end cap offered in one size. All three implant components will be manufactured from titanium 6AL-4V.
INTENDED USE:
The Ascension® Ankle Fusion Nail System is intended for the following:
- . Charcot Foot
- Avascular necrosis of the talus .
- Failed total ankle arthroplasty .
- . Trauma (malunited tibial pilon fracture)
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular . accident, paralysis or other neuromuscular disease
- . Revision ankle arthrodesis
- . Neuroarthropathy
- . Rheumatoid arthritis
- Osteoarthritis .
- Pseudoarthrosis .
1
- Post-Traumatic arthrosis .
- Previously infected arthrosis .
- Severe end stage degenerative arthritis t
- Severe defects after tumor resection .
- Pantalar arthrodesis .
BASIS OF SUBSTANTIAL EQUIVALENCE:
Ascension Orthopedics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials and indications.
The worst-case cross sectional areas of the device are located at the screw holes and slots. The nail's cross sectional area directly affects the bending strength of the nail. An engineering analysis was completed on the proposed device and the predicate devices. Results demonstrate equivalence in bending strength to the legally marketed predicate devices.
2
Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes extending from its body, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 12 2010
Ascension Orthopedics. Inc. % Mr. Stan Harris 8700 Cameron Road, Suite 100 Austin, TX 78754-3832
Re: K100925
Trade/Device Name: Ascension Ankle Fusion Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 25, 2010 Received: June 28, 2010
Dear Mr. Harris:
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. Iisting 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 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 - Mr. Stan Harris
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Kaibare Buehup
XX
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Submission Ankle Fusion Nail System March 17, 2010
Indications for Use Statement 3
K/00925 510(K) Number.
Device Name:
Ascension® Ankle Fusion Nail System
Indications for Use:
The Ascension® Ankle Fusion Nail System is intended for the following:
- Charcot Foot .
- Avascular necrosis of the talus .
- Failed total ankle arthroplasty .
- Trauma (malunited tibial pilon fracture) .
- Severe deformity or instability as a result of talipes equinovarus, cerebral . vascular accident, paralysis or other neuromuscular disease
- Revision ankle arthrodesis ●
- Neuroarthropathy .
- . Rheumatoid arthritis
- Osteoarthritis .
- . Pseudoarthrosis
- Post-Traumatic arthrosis .
- Previously infected arthrosis .
- Severe end stage degenerative arthritis .
- Severe defects after tumor resection .
- . Pantalar arthrodesis
Prescription Use × (Part 21 CFR 801Subpart B) OR Over-The-Counter Use (Part 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical Orthopedic
form
Division of Surgical, Orthopedic, and Restorative Devices
Page 11 of 78
510(k) Number K100925