(138 days)
No
The device description and intended use are purely mechanical, describing a shoulder implant system. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a system for shoulder replacement surgery, indicated for treating painful and disabling joint diseases and fractures, which directly addresses medical conditions and aims to restore function.
No
The device description clearly states it is a "Shoulder Bipolar System" consisting of components like "Humeral Head Component" and "Humeral Stem," intended for use as a "hemi-shoulder system" or "shoulder replacement device." These are all components of a prosthetic implant, not a diagnostic tool. The indications for use describe conditions that would necessitate such an implant, not conditions that the device would diagnose.
No
The device description clearly outlines physical components made of metal and UHMWPE, which are implanted in 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Osteonics Solar™ Shoulder Bipolar System is a surgical implant used for shoulder replacement. It consists of physical components (humeral head, modular head, humeral stem) designed to be implanted into the body.
- Intended Use: The intended uses are all related to treating painful and disabling conditions of the shoulder through surgical intervention and replacement of the joint components.
There is no mention of this device being used to analyze samples from the body or provide diagnostic information based on such analysis. It is a therapeutic device used in surgery.
N/A
Intended Use / Indications for Use
The indications for the Osteonics Solar™ Shoulder Bipolar System are:
- Aseptic necrosis of the humeral head .
- Painful, disabling joint disease of the shoulder resulting from: degenerative ● arthritis, rheumatoid arthritis or post-traumatic arthritis.
- . Proximal humeral fracture and/or dislocation
- Clinical management problems where arthrodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
- Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
Product codes
MJT
Device Description
The Osteonics" Solar™ Shoulder Bipolar System consists of an Osteonics Solar™ Shoulder Bipolar Humeral Head Component, an Osteonics 22 mm Solar™ Shoulder Bipolar Modular Head and an Osteonics Solar™ Shoulder Humeral Stem. The humeral stem was determined substantially equivalent via 510(k) K955731. There have been no modifications made to the humeral stem. The bipolar head component consists of three preassembled pieces: a metal shell, UHMWPE insert and locking ring. The component will be sold preassembled. The metallic shell is manufactured from ASTM F75 cobalt chromium alloy. The 22 mm bipolar modular head is manufactured from ASTM 1537 cobalt chromium alloy. The Osteonics Solar™ cobalt chromium Shoulder Bipolar Components (Bipolar Head Component and 22 mm Bipolar Modular Head) are intended to be used in cementless applications and as a hemi-shoulder system. Used as a hemi-shoulder replacement device, the Osteonics Solar™ Shoulder, Bipolar Humeral Head Components are intended to articulate directly with the anatomic glenoid.
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)
Biomet Bi-Angular Bi-Polar Shoulder System
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
JUL 20 1999
Osteonics" Solar256 Shoulder Bipolar System
712
510(k) Summary
510(k) Premarket Notification Summary of Safety and Effectiveness for the Osteonics Solar™ Shoulder Bipolar System
Submission Information
| Name and Address of the Sponsor
of the 510(k) Submission: | Howmedica Osteonics Corp.
59 Route 17
Allendale, NJ 07401-1677 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Ariemma
Regulatory Affairs Specialist |
| Date of Summary Preparation: | April 1, 1999 |
| Device Identification | |
| Proprietary Name: | Osteonics® Solar™ Shoulder Bipolar
System |
| Common Name: | Bi-Polar Shoulder Components |
| Classification Name and Reference: | Shoulder joint metal/polymer
Semi-constrained cemented
prosthesis
21 CFR §888.3660
Shoulder joint humeral (hemi-
shoulder) metallic uncemented
prosthesis
21 CFR §888.3690 |
Predicate Device Identification
The Osteonics" Solar™ Shoulder Bipolar components are substantially equivalent to the following competitive device, which have previously been determined substantially equivalent by FDA:
- Biomet Bi-Angular Bi-Polar Shoulder System .
1
Osteonics" Solar 14 Shoulder Bipolar System
510(k) Summary
Device Description
The Osteonics" Solar™ Shoulder Bipolar System consists of an Osteonics Solar™ Shoulder Bipolar Humeral Head Component, an Osteonics 22 mm Solar™ Shoulder Bipolar Modular Head and an Osteonics Solar™ Shoulder Humeral Stem. The humeral stem was determined substantially equivalent via 510(k) K955731. There have been no modifications made to the humeral stem. The bipolar head component consists of three preassembled pieces: a metal shell, UHMWPE insert and locking ring. The component will be sold preassembled. The metallic shell is manufactured from ASTM F75 cobalt chromium alloy. The 22 mm bipolar modular head is manufactured from ASTM 1537 cobalt chromium alloy. The Osteonics Solar™ cobalt chromium Shoulder Bipolar Components (Bipolar Head Component and 22 mm Bipolar Modular Head) are intended to be used in cementless applications and as a hemi-shoulder system. Used as a hemi-shoulder replacement device, the Osteonics Solar™ Shoulder, Bipolar Humeral Head Components are intended to articulate directly with the anatomic glenoid.
Intended Use:
Indications:
The indications for the Osteonics Solar™ Shoulder Bipolar System are:
- Aseptic necrosis of the humeral head .
- Painful, disabling joint disease of the shoulder resulting from: degenerative ● arthritis, rheumatoid arthritis or post-traumatic arthritis.
- . Proximal humeral fracture and/or dislocation
- Clinical management problems where arthrodesis or alternative reconstructive ● techniques are less likely to achieve satisfactory results.
- Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
Statement of Technological Comparison:
The subject devices (Bipolar Humeral Head and Bipolar Modular Head) are substantially equivalent to the bipolar components (Bi-Polar Shell and Bi-
2
Osteonics" Solar TM Shoulder Bipolar System
510(k) Summary
Angular/Bi-Polar Modular Heads) of the predicate Biomet Bi-Angular Bi-Polar Shoulder System Components in all material and design aspects, indications, and intended use.
Summary
Based on the information presented above, the substantial equivalence of the Osteonics Solar™ Shoulder Bipolar Component to other legally marketed, class III bipolar shoulder components is demonstrated.
3
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 20 - 1999
Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey
к990712 Re: K990712
Trade Name: Osteonics® Solar™ Shoulder Bipolar System Regulatory Class: III Product Code: MJT Dated: March 3, 1999 Received: March 4, 1999
Dear Ms. Ariemma:
We have reviewed your Section 510(k) notification of intent to we have leviewed your boosed. Ove and we have determined the market the device is ly equivalent (for the indications for device is substancially cyca) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Commerce prior amendments, or to devices that have been Medical Devrec Amendison, with the provisions of the Federal You may, therefore, Food, Drug, and Cosmetic Act (Act). market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. of the nec. The goss 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 (Premarket Approval), 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 895. ਜਿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
4
Page 2 - Ms. Karen Ariemma
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sist. Prour device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K990712
Device Name: Osteonics® Solar™ Shoulder Bipolar System
The subject components of the Osteonics Solar™ Shoulder Bipolar System are single-use devices which are sold sterile and are intended for use with only the other components of the commercially available Osteonics Solar™ Shoulder System.
The indications for the Osteonics Solar™ Shoulder Bipolar System components, in keeping with those of other legally devices are as follows:
Indications:
- Aseptic necrosis of the humeral head .
- Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis or . post-traumatic arthritis.
- Proximal humeral fracture and/or dislocation �
- Clinical management problems where arthrodesis or alternative techniques are less likely to . achieve satisfactory results.
- Pathological conditions or age considerations which indicate a more conservative glenoid procedure and � avoidance of the use of bone cement in the glenoid.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Deedee