K Number

Device Name

SELECT SHOULDER OFFSET HUMERAL HEAD COMPONENTS

Manufacturer

SULZER ORTHOPEDICS, INC.

Date Cleared

1997-08-07

(90 days)

Product Code

KWS HSD KWT

Regulation Number

888.3660

Intended Use

The Select Shoulder Offset Humeral Heads, when used with one of the Select Shoulder Humeral Stems and Glenoid Components (if applicable), are intended for use in treatment of the following: - Patient conditions, including but not limited to, noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures. - Those patients with failed previous surgery where pain, deformity, or dysfunction persists. - Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the humeral neck, arthrodesis or hemiarthroplasty. - Cuff tear arthropathy. - Avascular necrosis or osteonecrosis of the humeral head. - Tumor resection.

Device Description

The Select Shoulder Offset Humeral Heads are metallic components manufactured from cobalt chrome alloy (CoCrMo). The heads, once impacted onto one of the Select Shoulder humeral stems, are designed to articulate with the normal human glenoid or with a replacement all-poly glenoid component. The humeral heads feature a female taper which allows for attachment to the male taper of the Sulzer Orthopedics Select Shoulder Humeral Stems. The articulating surface of the head is polished. The underside of the head, with the exception of the taper attachment feature, may be either polished or grit blasted. Similar to the face of a clock, the underside of the head is numbered from 1-12, giving the surgeon the ability to reference and select the position of the head relative to the glenoid. The location of the female taper is offset from center, thus permitting ease of insertion into the joint, allowing closer replication of the normal head anatomy permitting accurate anatomic soft tissue balancing, and providing greater contact with the glenoid when the humerus is in a normal resting position. The heads are available in a variety of heights and diameters. The humeral heads are designed for use with Sulzer Orthopedics Humeral Stems and/or glenoid components which come in a variety of sizes for increased stability of the glenohumeral joint.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

KWS, KWT, HSD

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities, let alone AI/ML.

Therapeutic

Yes

The device, the Select Shoulder Offset Humeral Heads, is intended for treatment of various patient conditions, including degenerative and inflammatory joint diseases, fractures, dislocations, and failed surgeries, aiming to restore normal anatomy and function.

Diagnostic

The device description clearly states that the Select Shoulder Offset Humeral Heads are "metallic components manufactured from cobalt chrome alloy (CoCrMo)" designed to be "impacted onto one of the Select Shoulder humeral stems" to "articulate with the normal human glenoid or with a replacement all-poly glenoid component." This describes a prosthetic implant used for treatment, not a device used to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device description clearly states the device is a metallic component manufactured from cobalt chrome alloy (CoCrMo) and describes its physical characteristics and function as a physical implant.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Description: The description clearly states that the Select Shoulder Offset Humeral Heads are metallic components designed to be implanted into the human body as part of a shoulder replacement system. They are used to articulate with the glenoid (either the natural one or a replacement).
Intended Use: The intended use describes the conditions for which the device is used in the treatment of patients, such as osteoarthritis, fractures, and failed previous surgeries. This is a therapeutic use, not a diagnostic one based on analyzing bodily specimens.
Lack of IVD Characteristics: The description does not mention any interaction with bodily fluids or tissues for the purpose of diagnosis. There is no mention of analyzing biomarkers, performing chemical reactions, or any other typical IVD activities.

In summary, the Select Shoulder Offset Humeral Heads are a surgical implant used for the treatment of various shoulder conditions, not a device used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Select Shoulder Offset Humeral Heads, when used with one of the Select Shoulder Humeral Stems and Glenoid Components (if applicable), are intended for use in treatment of the following:

Patient conditions, including but not limited to, noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures.
Those patients with failed previous surgery where pain, deformity, or dysfunction persists.
Failed previous surgery, including joint reconstruction, internal fixation, nonunion of the humeral neck, arthrodesis or hemiarthroplasty.
Cuff tear arthropathy.
Avascular necrosis or osteonecrosis of the humeral head.
Tumor resection.

Product codes

KWS, KWT, HSD

Device Description

Testing indicated that the pulloff strengths for the Select Shoulder Offset Humeral Heads were comparable to currently marketed devices. Contact area testing indicated that the offset heads provide adequate contact area at various levels of abduction.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Humeral head, glenoid, glenohumeral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

The Select Shoulder CoCr Humeral Heads are similar to those of the Tornier Aequalis Shoulder System, the Depuy Global Total Shoulder System, the Biomet Bio-Modular Total Shoulder, the Zimmer Fenlin Total Shoulder, the Kirschner Modular Shoulder System, the 3M/Orthomet Modular Neer II Shoulder System, and the Encore Foundation Shoulder System.

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.”

Summary

510(k) SUMMARY

April 29, 1997

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21CFR 807, this is to serve as a 510(k) Summary for the Sulzer Orthopedics Inc. Select® Shoulder Offset Humeral Heads.

| Submitter: | Sulzer Orthopedics Inc.
9900 Spectrum Drive
Austin, TX 78717
(512) 432-9900 |
|----------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Jacquelyn Hughes
Manager, Regulatory Affairs |
| Classification Name: | No formal classification has been established for humeral head
components. |
| Common/Usual Name: | Humeral Head Components |
| Trade/Proprietary: | Select® Shoulder Offset Humeral Heads |

Product Description/Substantial Equivalence:

UUUZZA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mitchell A. Dhority, RAC Senior Regulatory Affairs Specialist ---------SulzerMedica ¨ Sulzer Orthopedics, Inc. AUG - 7 1997 9900 Spectrum Drive Austin, Texas 78717

Re : K971715 Trade Name: Select Shoulder Offset Humeral Heads Regulatory Class: III Product Codes: KWS, KWT, and HSD Dated: May 7, 1997 Received: May 9, 1997

Dear Mr. Dhority:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that,

Page 2 - Mitchell A. Dhority, RAC

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. concerning your device in the Federal Register. Please note: " 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.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in yitro 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 the Office of Compliance at (301) 594-4639. Also, please note 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,

ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

|
|

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Select Shoulder Offset

Device Name: Humeral Heads

Indications for Use:

Patient conditions, including but not limited to, noninflammatory degenerative joint 1. disease (NIDJD), e.g., osteoarthritis or post-traumatic arthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
Complex acute fractures, fracture-dislocations of the humeral head, malunion or non-2. union of a small osteoporotic head fragment, chronic, recurrent or acute dislocation with loss of humeral head cartilage, or large impression fractures.
Those patients with failed previous surgery where pain, deformity, or dysfunction 3. persists.
Failed previous surgery, including joint reconstruction, internal fixation, nonunion of 4. the humeral neck, arthrodesis or hemiarthroplasty.
Cuff tear arthropathy. న.
Avascular necrosis or osteonecrosis of the humeral head. 6.
1. Tumor resection.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

evice Evaluation (ODE)

(Division Sign-Off)
Division of Genarai Restorative Devices
510(%) Numbar. K971715

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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