(84 days)
The DVO™ Extended Articulation Humeral Heads for use in hemi-shoulder replacement are indicated for:
- Ununited humeral head fractures;
- Avascular necrosis of the humeral head.
- Rotator cuff tear arthropathy.
Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.
The Extended Articulation Humeral Heads are an addition to the previously cleared modular DVO Total and Hemi Shoulder System. The cobalt chrome alloy, semispherical heads mate with the previously cleared humeral stems through a locking taper. The heads are highly polished. They do not articulate with the previously cleared glenoids as they are intended to be used in hemi-arthroplasty applications only.
The heads are available in four sizes, 44 to 56mm, in 4mm increments, and in heights of 18 and 21 mm.
The provided text is for a 510(k) premarket notification for a medical device called "Extended Articulation Humeral Heads." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on detailed performance studies with acceptance criteria in the way AI/ML devices typically present them.
Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving the device meets those criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies, as described in your prompt.
Instead, the submission states:
- Comparison to Predicates: "The DVO Extended Articulation Humeral Heads are similar to the listed predicate devices in intended use for hemi shoulder replacement, indications for use, design, materials of construction (cobalt chrome alloy), methods of sterilization (gamma irradiation), packaging, and manufacturing methods."
This means the device's acceptance is based on its similarity to previously approved devices, not on a new, explicit performance study against pre-defined acceptance criteria as would be typical for a novel diagnostic or AI-powered solution.
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K073331 (pg. 1 of 2)
Image /page/0/Picture/1 description: The image shows the logo for DVO Extremity Solutions. The logo consists of the letters "DVO" in large, bold, white font against a black background. Below the letters, the words "Extremity Solutions" are written in a smaller, bold, black font. The address "720 E. Winona Ave., Warsaw, IN 46580" is printed below the company name.
FEB 19 2000
510(k) Summary of Safety and Effectiveness
| SUMMARY PREPARED: | November 26, 2007 |
|---|---|
| 510(k) SPONSOR andAPPLICANT: | DVOTM Extremity Solutions, LLC720 E. Winona Ave., Warsaw IN 46580 |
| CONTACT PERSON: | Jeff Ondrla,Vice President, Product Development(574) 527-9951JOndrla@Tornier.com |
| TRADE NAME: | Extended Articulation Humeral Heads |
| COMMON NAMES: | Shoulder prosthesis, humeral head |
| CLASSIFICATION,CLASS andPRODUCT CODE: | 21 CFR 888.3690, Class II, 87 HSD |
| PREDICATE DEVICES: | DePuy Global Advantage Extended Humeral Heads,K000575DVO Total and Hemi Shoulder System, K060988 |
DEVICE DESCRIPTION:
The Extended Articulation Humeral Heads are an addition to the previously cleared modular DVO Total and Hemi Shoulder System. The cobalt chrome alloy, semispherical heads mate with the previously cleared humeral stems through a locking taper. The heads are highly polished. They do not articulate with the previously cleared glenoids as they are intended to be used in hemi-arthroplasty applications only.
The heads are available in four sizes, 44 to 56mm, in 4mm increments, and in heights of 18 and 21 mm.
(Continued on next page)
Page 1 of 2
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K073331 (pg. 2 of 2)
Image /page/1/Picture/1 description: The image shows the logo for DVO Extremity Solutions. The logo has the letters DVO in a large, bold font at the top. Below that is the text "Extremity Solutions" in a smaller, bold font. The address "720 E. Winona Ave., Warsaw, IN 46580" is printed below the company name.
510(k) Summary of Safety and Effectiveness
INTENDED USE:
The DVO " Total Extended Articulation Humeral Heads are intended for use in hemishoulder arthroplasty.
INDICATIONS FOR USE:
The DVO™ Total Extended Articulation Humeral Heads, for use in hemi-shoulder replacement, are indicated for:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
-
- Rotator cuff tear arthropathy.
Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Humeral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.
COMPARISON TO PREDICATES:
The DVO Extended Articulation Humeral Heads are similar to the listed predicate devices in intended use for hemi shoulder replacement, indications for use, design, materials of construction (cobalt chrome alloy), methods of sterilization (gamma irradiation), packaging, and manufacturing methods.
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
FEB 19 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DVOTM Extremity Solutions, LLC % Mr. Jeff Ondrla Vice President, Product Development 720 East Winona Avenue Warsaw, Indiana 46580
Re: K073331
Trade/Device Name: DVOTM Extended Articulation Humeral Heads Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis Regulatory Class: Class II Product Code: HSD Dated: November 26, 2007 Received: December 11, 2007
Dear Mr. Ondrla:
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
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Page 2 - Mr. Jeff Ondrla
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. 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K073331
Device Name: DVOTM Extended Articulation Humeral Heads
Indications for Use: The DVO™ Extended Articulation Humeral Heads for use in hemi-shoulder replacement are indicated for:
-
- Ununited humeral head fractures;
-
- Avascular necrosis of the humeral head.
-
- Rotator cuff tear arthropathy.
Humeral stems and glenoids labeled "for cemented use only" are indicated only for use with bone cement. Hurneral stems are also indicated for press-fit uncemented use or for use with bone cement. These are sterile, single use devices.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milkman
(Division Sign-Of (Division of General, Restorative, Division of Neurological Devices
Page 1 of 1
510(k) Number
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.