K Number

Device Name

Manufacturer

HOWMEDICA OSTEONICS CORP.

Date Cleared

1999-07-20

(138 days)

Product Code

MJT

Regulation Number

N/A

Type

Traditional

Panel

Orthopedic

Reference & Predicate Devices

K955731

Predicate For

N/A

Intended 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.

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.

AI/ML Overview

This document is a 510(k) Premarket Notification summary for the Osteonics® Solar™ Shoulder Bipolar System. It outlines the device description, intended use, and claims of substantial equivalence to a predicate device. This type of submission generally does not include detailed performance studies with acceptance criteria in the way that, for example, a submission for diagnostic software would.

Here's an analysis of why the requested information is largely absent in this document, based on the nature of a 510(k) for a medical implant:

Medical Device Class III (Prosthesis): The device is classified as Class III (Shoulder joint metal/polymer Semi-constrained cemented prosthesis and Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis). For Class III devices, substantial equivalence is key in a 510(k). This typically involves demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness. This often relies on bench testing, materials testing, and mechanical/wear testing rather than clinical studies with "acceptance criteria" and "device performance" in the terms usually associated with AI or diagnostic device performance.
Focus on Substantial Equivalence: The primary goal of this 510(k) is to demonstrate that the Osteonics® Solar™ Shoulder Bipolar System is "substantially equivalent" to an existing, legally marketed device (the Biomet Bi-Angular Bi-Polar Shoulder System). This means the focus is on comparing the design, materials, and intended use to the predicate, not necessarily on new, independent clinical studies with performance metrics.
Missing Information: The document does not contain the following information as it is generally not required for this type of 510(k) submission:
- Table of acceptance criteria and reported device performance: This document doesn't provide specific performance metrics like sensitivity, specificity, or accuracy that would be found in a study for a diagnostic device. The "performance" in this context would likely refer to mechanical and material properties compared to the predicate.
- Sample size and data provenance for a "test set": There isn't a "test set" in the context of clinical images or patient data for algorithmic performance.
- Number of experts and qualifications for ground truth: Ground truth in this context would likely involve engineering specifications, material standards, and clinical outcomes from the predicate device's history, not expert consensus on image interpretation.
- Adjudication method: Not applicable for this type of device.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for a physical implant, not a diagnostic algorithm involving human readers.
- Standalone algorithm performance: Not applicable, as this is not an algorithm.
- Type of ground truth used: For mechanical devices, ground truth is typically engineering specifications, material properties, and established clinical success of predicate devices.
- Sample size for training set/How ground truth for training set was established: Not applicable, as this is not an AI/ML device requiring training data.

Summary of Information Available in the Provided Text (and what is not):

Based on the provided text, the device is a medical implant (shoulder bipolar system), and the submission is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the questions related to clinical study performance metrics, AI/ML algorithms, and expert ground truth are not addressed in this type of document.

What is present:

Predicate Device: Biomet Bi-Angular Bi-Polar Shoulder System.
Intended Use/Indications: Aseptic necrosis of the humeral head; Painful, disabling joint disease of the shoulder (degenerative, rheumatoid, 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 that indicate a more conservative glenoid procedure and avoidance of bone cement in the glenoid.
Device Components & Materials: Bipolar Humeral Head Component, 22 mm Solar™ Shoulder Bipolar Modular Head, and Solar™ Shoulder Humeral Stem. Metallic shell is ASTM F75 cobalt chromium alloy. Modular head is ASTM 1537 cobalt chromium alloy. UHMWPE insert and locking ring in the bipolar head component.
Claim of Equivalence: The subject devices (Bipolar Humeral Head and Bipolar Modular Head) are substantially equivalent to the bipolar components of the predicate (Biomet Bi-Angular Bi-Polar Shoulder System Components) in all material and design aspects, indications, and intended use.

In conclusion, the requested information regarding "acceptance criteria" through a "study that proves the device meets the acceptance criteria" as defined by performance metrics (like sensitivity/specificity) and clinical study design (sample sizes, expert ground truth, MRMC, etc.) is not present in this 510(k) summary because this type of submission for a physical implant does not typically involve such studies. Instead, the "proof" for substantial equivalence relies on comparison of design, materials, manufacturing, and intended use to a legally marketed predicate device, along with bench testing/materials testing to ensure equivalent safety and performance.

Summary

{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 Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677
Contact Person:	Karen AriemmaRegulatory Affairs Specialist
Date of Summary Preparation:	April 1, 1999
Device Identification
Proprietary Name:	Osteonics® Solar™ Shoulder BipolarSystem
Common Name:	Bi-Polar Shoulder Components
Classification Name and Reference:	Shoulder joint metal/polymerSemi-constrained cementedprosthesis21 CFR §888.3660Shoulder joint humeral (hemi-shoulder) metallic uncementedprosthesis21 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}------------------------------------------------

K990712

Osteonics" Solar 14 Shoulder Bipolar System

510(k) Summary

Device Description

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}------------------------------------------------

K990712

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

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Deedee

Regulation Number and Section

N/A