(70 days)
Not Found
No
The device description focuses on the material, shape, and mechanical properties of a physical implant, with no mention of software, algorithms, or data processing.
Yes
The device is intended to replace the lunate bone and is surgically implanted to treat conditions like avascular necrosis, osteoarthritis, and long-standing dislocations, which aligns with the definition of a therapeutic device.
No
The device is a replacement implant for the lunate bone, designed to treat existing conditions rather than to identify or diagnose them.
No
The device description clearly indicates it is a physical implant made of pyrocarbon and graphite, intended for surgical implantation in the wrist. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Ascension® PyroCarbon Lunate is a surgical implant designed to replace a bone in the wrist. It is a physical device implanted into the body, not used to test samples outside the body.
- Intended Use: The intended use is for surgical replacement of the lunate bone due to specific medical conditions. This is a therapeutic intervention, not a diagnostic test.
Therefore, based on the provided information, the Ascension® PyroCarbon Lunate is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of:
- Avascular necrosis (Kienboch's disease) .
- Localized osteoarthritic changes
- Long-Standing dislocations .
Product codes (comma separated list FDA assigned to the subject device)
KWN
Device Description
The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentially the same shape as the native lunate bone. The Lunate implant acts as an articulating spacer to maintain the relationship of adjacent carpal bones after excision and to maintain mobility of the wrist. The articular concavity that captures the capitate is more exaggerated to enhance stability. The Lunate implant has two suture holes that allow fixation of the implant to the adjacent scaphoid and triquetrium bones to provide temporary postoperative stability while a capsuloligamentous system forms around the implant. The Ascension Pyrocarbon Lunate is constructed of a high strength On-X® PyroCarbon layer deposited on a graphite substrate. The graphite is impregnated with tungsten making the Lunate implant radiopaque. The Ascension Pyrocarbon Lunate is available in 5 sizes for use in left or right applications. Device components are provided sterile in individual packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lunate bone in the proximal carpal row of the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was performed on the Pyrocarbon Lunate These test results demonstrate that the Ascension Lunate's strength and endurance are adequate to ensure device safety.
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
§ 888.3750 Wrist joint carpal lunate polymer prosthesis.
(a)
Identification. A wrist joint carpal lunate prosthesis is a one-piece device made of silicone elastomer intended to be implanted to replace the carpal lunate bone of the wrist.(b)
Classification. Class II.
0
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| 6 | 510(k) Summary | K080997 pg 1 |
|---|---|---|
| SUBMITTER NAME: | Ascension Orthopedics, Inc. | |
| 8700 Cameron Road, #100 | ||
| Austin, TX 78754-3832 | ||
| 510(k) CONTACT: | Debbie Stearns | JUN 17 2008 |
- 510(k) CONTACT: Debbie Stearns Phone: (512) 836-5001 x1548
Ascension® PyroCarbon Lunate TRADE NAME:
Prosthesis, Wrist Carpal Lunate COMMON NAME:
CLASSIFICATION: 21 CFR 888.3750
PRODUCT CODE: KWN
- Orthopedic PANEL:
PREDICATE DEVICES:
K864491 - Swanson Titanium Carpal Lunate Implant K061451 - Ascension PyroCarbon CMC
DEVICE DESCRIPTION:
The Ascension® PyroCarbon Lunate is an anatomically designed lunate replacement with essentially the same shape as the native lunate bone. The Lunate implant acts as an articulating spacer to maintain the relationship of adjacent carpal bones after excision and to maintain mobility of the wrist. The articular concavity that captures the capitate is more exaggerated to enhance stability. The Lunate implant has two suture holes that allow fixation of the implant to the adjacent scaphoid and triquetrium bones to provide temporary postoperative stability while a capsuloligamentous system forms around the implant. The Ascension Pyrocarbon Lunate is constructed of a high strength On-X® PyroCarbon layer deposited on a graphite substrate. The graphite is impregnated with tungsten making the Lunate implant radiopaque. The Ascension Pyrocarbon Lunate is available in 5 sizes for use in left or right applications. Device components are provided sterile in individual packaging.
INTENDED USE:
The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of:
- Avascular necrosis (Kienboch's disease) .
- Localized osteoarthritic changes �
- Long-Standing dislocations .
1
510(k) Premarket Notification Device: Ascension® Lunate
K080947 pg 2 of 2 Page 13 of 141
BASIS OF SUBSTANTIAL EQUIVALENCE:
A comparison of the Ascension Lunate and the Swanson Titanium Carpal Implant (K864491) show similar design features, surgical technique and indications. The Ascension Lunate and the Ascension CMC (K061451) are made of the same material and both are intended to articulate with carpal bone.
Performance testing was performed on the Pyrocarbon Lunate These test results demonstrate that the Ascension Lunate's strength and endurance are adequate to ensure device safety.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2008
Director, Clinical Affairs 8700 Cameron Road, #100 Austin, Texas 78754-3832
Ascension Orthopedics, Inc.
% Ms. Debbie Steams
Re:
K080997 Trade/Device Name: Ascension PyroCarbon Lunate Regulation Number: 21 CFR 888.3750 Regulation Name: Wrist joint carpal lunate polymer prosthesis Regulatory Class: Class II Product Code: KWN Dated: April 4, 2008 Received: April 16, 2008
Dear Ms. Stearns:
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. Debbie Stearns
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 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. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
5 Indications for Use Statement
KO80997 510(K) Number.
Device Name:
Ascension® PyroCarbon Lunate
Indications for Use:
The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of:
- Avascular necrosis (Kienboch's disease)
- Localized osteoarthritic changes
- Long-Standing dislocations
OR Prescription Use × Over-The-Counter Use (Part 21 CFR 801Subpart B) (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)
Neil Re al for mkm
Division Sig Division of General, Restorative, and Neurological Devices
510(k) Number K080997