(240 days)
Not Found
No
The device description and intended use are for a mechanical shoulder implant system. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is intended for use in total or hemi-arthroplasty to address severely painful and/or disabled joints, fracture/dislocations, and other clinical problems, which are therapeutic interventions.
No
The device is a DVO™ Total and Hemi Shoulder System, intended for use in total or hemi-arthroplasty of the shoulder. This is a surgical implant designed to replace part or all of the shoulder joint, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is comprised of physical components like a humeral stem, humeral heads, and glenoids made of materials like titanium, cobalt chrome, and polyethylene. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use in total or hemi-arthroplasty, which is a surgical procedure to replace a joint. This is a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The description details the components of a shoulder implant (humeral stem, heads, glenoids) made of materials like titanium, cobalt chrome, and polyethylene. These are materials used for surgical implants, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the DVOTM Total and Hemi Shoulder System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DVO™ Total and Hemi Shoulder System is intended for use in total or hemi-arthroplasty.
The DVO™ Total and Hemi Shoulder System is indicated for:
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
- Fracture/dislocations of the proximal humerus where the articular surface is severely comminuted, 2. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (c.g., revision of a failed primary component).
Hemi-shoulder replacement is also 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 indicated for press-fit uncemented use or for use with bone cement.
This is a single use device.
Product codes
KWS, HSD
Device Description
This sterile modular total and hemi shoulder system is comprised of a humeral stem, two styles of humeral heads (standard and exentric) and two styles of glenoids (pegged or keeled). The heads mate on the stems through a locking taper. The heads are highly polished and articulate with the glenoids.
The humeral stems are offered in two lengths: standard (110mm with diameters of 6 to 16mm) or long (200 to 220mm in length with diameters of 8 to 14mm). The stems are fluted, except for the 6mm diameter stem. The stems also have fins with suture holes. The head is available in 15 standard sizes (40 to 56mm in heights of 15, 18 and 21 mm) and 10 eccentric sizes (40 to 56mm in heights of 18mm or 21mm).
Materials include titanium humeral stems, cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
K060988 page 143
Image /page/0/Picture/1 description: The image shows the letters "DVO" in white font on a black background. The letters are large and bold, and they are the main focus of the image. The letters are evenly spaced and aligned horizontally. The image is simple and minimalist, with a focus on the letters themselves.
DEC - 6 2006
| Extremity Solutions
| 720 E. Winona Ave., Warsaw, IN 46580 | 510(k) Summary of Safety and Effectiveness |
|---|---|
| SUMMARY PREPARED: | 28 NOVEMBER 2006 |
| 510(k) SPONSOR/APPLICANT: | DVO TM Extremity Solutions, LLC |
| 720 E. Winona Ave., Warsaw IN 46580 | |
| 510(k) PREPARER and | |
| CONTACT PERSON: | Dina L. Weissman, J.D. |
| P.O. Box 205, Derby CT 06418 | |
| Tel: (203) 736-8631, Email: dina.weissman@sbcglobal.net | |
| TRADE NAME: | Total and Hemi Shoulder System |
| COMMON NAMES: | Shoulder prosthesis, humeral head |
| CLASSIFICATION, CLASS and | |
| DEVICE PRODUCT CODE: | 21 CFR 888.3660 Class II, 87 KWS |
| 21 CFR 888.3690, Class II, 87 HSD | |
| PREDICATE DEVICES: | The DePuy Global shoulder system cleared in: |
| • Total Shoulder, K905786, K914000 | |
| • Advantage Shoulder Humeral Stem and Eccentric Head, K992065 |
DEVICE DESCRIPTION:
This sterile modular total and hemi shoulder system is comprised of a humeral stem, two styles of humeral heads (standard and exentric) and two styles of glenoids (pegged or keeled). The heads mate on the stems through a locking taper. The heads are highly polished and articulate with the glenoids.
The humeral stems are offered in two lengths: standard (110mm with diameters of 6 to 16mm) or long (200 to 220mm in length with diameters of 8 to 14mm). The stems are fluted, except for the 6mm diameter stem. The stems also have fins with suture holes. The head is available in 15 standard sizes (40 to 56mm in heights of 15, 18 and 21 mm) and 10 eccentric sizes (40 to 56mm in heights of 18mm or 21mm).
Materials include titanium humeral stems, cobalt chrome humeral heads and ultrahigh molecular weight polyethylene glenoids.
(Continued on next page)
Page 1 of 2
1
page 2/3
Image /page/1/Picture/1 description: The image shows the logo for DVO Extremity Solutions. The address 720 E. Winona Ave., Warsaw, IN 46580 is printed below the company name. The logo is in black and white.
510(k) Summary of Safety and Effectiveness
INTENDED USE:
The DVOTM Total and Hemi Shoulder System is intended for use in total or hemi-arthroplasty.
INDICATIONS FOR USE:
The DVO™ Total and Hemi Shoulder System is indicated for:
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or: 1. rheumatoid arthritis:
-
- Fracture/dislocations of the proximal humeru:) where the articular surface is severely comminuted. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
-
- Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary : omponent).
Hemi-shoulder replacement is also indicated for:
- Ununited humeral head fractures; 1.
-
- 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.
This is a single use device.
(Continued on next page)
Page 2 of 3
2
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Image /page/2/Picture/1 description: The image shows the logo for "DVO Extremity Solutions" along with their address. The logo is in bold, white letters against a black background. The address is "720 E. Winona Ave., Warsaw, IN 46580".
510(k) Summary of Safety and Effectiveness
COMPARISON TO PREDICATES:
The DVO Total and Hemi Shoulder System is similar to the listed predicate devices in intended use for total or hemi shoulder replacement, performance characteristics, materials of construction (titanum alloy, cobalt chrome alloy and UHMWPE), methods of sterilization (gamma irradiation), packaging, manufacturing methods and design. This is evidenced by comparison of technological characteristics, dimensional analysis and nonclinical testing.
Specifically, both the DVO subject devices and the Dr.Puy predicate devices are comprised of a humeral stem and a humeral head mating together with an articulating UHMWPE glenoved. The locking tapers for the head and stem are similar in both the subject and predicate systems,
The stems of both systems are offered in similar lengths (standard and long), with similar diameters. The stems are also similar in being tapered, fluted and having fins with suture holes,
The heads of both systems are of similar size and shape and are offered in standard or eccentric styles. Curvature sizes range from 40mm to 56mm with head heights of 15mm, 18mm and 21 coven
The UHMWPE glenoids of both systems are offer in both pegged and keeled configurations.
The systems also share equal indications for use.
From the standpoint of strength analysis, the subject @rvice is substantially equivalent to the predicate stems because its fatigue load carrying capability exceeds the predicate devices.
Page 3 of 3
3
Image /page/3/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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black.
DEC - 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DVO Extremity Solutions, LLC % Ms. Dina L. Weissman, J.D. P.O. Box 205 Derby. Connecticut 06418
Re: K060988
Trade/Device Name: DVOTM Total and Hemi Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained, cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: November 29, 2006 Received: December 1, 2006
Dear Ms. Weissman:
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 commercc 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 – Ms. Dina L. Weissman, J.D.
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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buehler
Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K060988
Device Name: DVOTM Total and Hemi Shoulder System
Indications for Use: The DVO™ Total and Hemi Sl»vulder System is indicated for:
-
- A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis:
- Fracture/dislocations of the proximal humerus where the articular surface is severely comminuted, 2. separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
- నే. Other difficult clinical problems where shoulder anthrodesis or resection arthroplasty are not acceptable (c.g., revision of a failed primary component).
Hemi-shoulder replacement is also 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 indicated for press-fit uncemented use or for use with bone cement.
This is a single use device.
Prescription Use XXXXXX Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Sarbaue Bosens Armson
Division Sign. Off.
Division of Ger Compt 11:10:00 and Neurological Device
Page 1 of 1
510(k) Number Kolo0988