(68 days)
Not Found
No
The device description and performance studies focus on the materials and mechanical properties of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a prosthesis system indicated for replacing the ulnar head and stem due to various medical conditions, positioning it as a treatment for these conditions.
No
Explanation: The device is a prosthesis system indicated for replacement of the ulnar head and stem, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it consists of physical components: an intramedullary ulnar stem, a ulnar head, and a surgical instrumentation set. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing the ulnar head and stem due to various medical conditions affecting the wrist. This is a therapeutic device used in vivo (within the body).
- Device Description: The device is described as an intramedullary stem and ulnar head, which are physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to treat a physical condition within the body.
N/A
Intended Use / Indications for Use
The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.
Product codes
KXE
Device Description
The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ulnar head and stem (wrist joint)
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
The OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System complies with the requirements of listed FDA Recognized Consensus Standards.
- ISO 5832-2:1999, Implants for Surgery Metallic Materials Part 2: . Unalloved Titanium
- ISO 5832-3:1996, Implants for Surgery Metallic materials Part 3: . Wrought titanium 6-aluminium 4-vanadium alloy
- ISO 5832-12:1996, Implants for Surgery Metallic materials Part 12: . Wrought cobalt-chromium-molybdenum alloy
- ISO 7153-1:1991/Amd. 1:1999, Surgical instruments Metallic materials . - Part 1: Stainless steel
- ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar . and Wire for Surgical Instruments
- ASTM F138 97, Standard Specification for Wrought 18 Chromium-14 . Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- AAMI/ANSI/ ISO 11134:1993, Sterilization of health care products Re-. quirements for validation and routine control-industrial moist heat sterilization.
- . AAMI/ANSI ST46:2002, Steam Sterilization and Sterility Assurance in Health Care Facilities
The OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System is substantially equivalent to the uHead Ulnar Implant System that is legally marketed and distributed by Avanta Orthopaedics, Inc. This has been demonstrated through a 8-point technological comparison of features.
The blood and tissue contact materials used to fabricate the Herbert Ulnar Head Prosthesis System have a long history of safe usage in medical devices. Because the OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Herbert Ulnar Head Prosthesis System will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3810 Wrist joint ulnar (hemi-wrist) polymer prosthesis.
(a)
Identification. A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.(b)
Classification. Class II.
0
2902
Page 20 of 21
DEC 2 7 2004 Summary of Safety and Effectiveness for the Herbert Ulnar Head Prosthesis System
submitted by OrthoSurgical Implants, Inc. 12244 SW 130 St Miami, FL 33186 Phone: (305) 969-4545
| Contact Person: | Ricardo Schoening |
|---|---|
| Device Trade Name: | Herbert Ulnar Head Prosthesis System |
| Common Name: | Ulnar Head Prosthesis |
| Classification Name: | Wrist joint ulnar (hemi-wrist) polymer prosthesis per 21 CFR § |
| 888.3810 |
Identification of a Legally Marketed Predicate Device
The OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System is substantially equivalent to uHead Ulnar Implant System that is legally marketed and distributed by Avanta Orthopaedics, Inc. pursuant to premarket notification K010786.
Device Description
The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.
Intended Use
The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.
Summary of Technological Characteristics
An 8-point comparison of technological characteristics of the OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System and the predicate devices was performed. The devices were found to be substantially equivalent.
Summary of Performance Data
The OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System complies with the requirements of listed FDA Recognized Consensus Standards.
1
- ISO 5832-2:1999, Implants for Surgery Metallic Materials Part 2: . Unalloved Titanium
- ISO 5832-3:1996, Implants for Surgery Metallic materials Part 3: . Wrought titanium 6-aluminium 4-vanadium alloy
- ISO 5832-12:1996, Implants for Surgery Metallic materials Part 12: . Wrought cobalt-chromium-molybdenum alloy
- ISO 7153-1:1991/Amd. 1:1999, Surgical instruments Metallic materials . - Part 1: Stainless steel
- ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar . and Wire for Surgical Instruments
- ASTM F138 97, Standard Specification for Wrought 18 Chromium-14 . Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- AAMI/ANSI/ ISO 11134:1993, Sterilization of health care products Re-. quirements for validation and routine control-industrial moist heat sterilization.
- . AAMI/ANSI ST46:2002, Steam Sterilization and Sterility Assurance in Health Care Facilities
The OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System is substantially equivalent to the uHead Ulnar Implant System that is legally marketed and distributed by Avanta Orthopaedics, Inc. This has been demonstrated through a 8-point technological comparison of features.
The blood and tissue contact materials used to fabricate the Herbert Ulnar Head Prosthesis System have a long history of safe usage in medical devices. Because the OrthoSurgical Implants, Inc. Herbert Ulnar Head Prosthesis System meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Herbert Ulnar Head Prosthesis System will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized eagle-like symbol with three swooping lines forming the body and wings. The seal is black and white and appears to be of an official government entity.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 27 2004
Stuckenbrock Medizintechnik GmbH C/o Mr. Al Weisenborn OrthoSurgical Implants, Inc. 12244 SW 130 Street Miami, Florida 33186
Re: K042902
Trade/Device Name: Herbert Ulnar Head Prosthesis System Regulation Number: 21 CFR 888.3810 Regulation Name: Wrist joint ulnar (hemi-wrist) polymer prosthesis Regulatory Class: II Product Code: KXE Dated: September 27, 2004 Received: October 20, 2004
Dear Mr. Weisenborn:
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 - Mr. Al Weisenborn
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Alan Webb
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use - Indications for
Page 1 of 1
KO42905 510(k) Number (if known):
Device Name: Herbert Ulnar Head Prosthesis System
Indications for Use:
The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Division of General, Restorative and Neurological Devices
5110(k) Number K042602 Page 1 of 1