ABG II MODULAR HIP STEM

K092406 · Howmedica Osteonics Corp. · MEH · Nov 4, 2009 · Orthopedic

Device Facts

• Record ID: K092406
• Device Name: ABG II MODULAR HIP STEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: MEH · Orthopedic
• Decision Date: Nov 4, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3353
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ABG™ II Modular Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available compatible Howmedica Osteonics' acetabular components. Compatibility with the modular stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.

Device Story

Modular hip prosthesis system; consists of modular stem and modular neck. Designed for cementless, press-fit application in primary or revision total hip arthroplasty. Used with compatible Howmedica Osteonics femoral heads, bipolars, and acetabular components. Operated by orthopedic surgeons in clinical/surgical settings. Device replaces diseased/damaged hip joint components to alleviate pain and restore function. Mechanical fixation via press-fit; no active components or software.

Clinical Evidence

Bench testing only.

Technological Characteristics

Modular hip stem for cementless, press-fit application. Composed of modular stem and neck components. Compatible with various Howmedica Osteonics femoral heads and acetabular components. No software or electronic components.

Indications for Use

Indicated for patients requiring total hip replacement due to noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed previous treatments/devices, or proximal femur fractures (nonunion, femoral neck, trochanteric) with head involvement. Intended for cementless use only.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

• Stryker Modular Hip System
• Rejuvenate Monolithic Hip Size 4 Stem

Submission Summary (Full Text)

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K092406 (pg 1/3)

# 510(k) Summary of Safety and Effectiveness

| Proprietary Name: | ABG™ II Modular Hip Stem NOV - 4 2009 | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common Name: | Hip prosthesis | |
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semi-constrained<br>cemented or nonporous uncemented prosthesis, 21 CFR §888.3353<br><br>Hip joint metal/polymer/metal semi-constrained porous<br>coated uncemented prosthesis, 21 CFR §888.3358<br><br>Hip joint metal/polymer semi-constrained cemented<br>prosthesis 21 CFR §888.3350<br><br>Hip joint femoral (hemi-hip) metal/polymer cemented or<br>uncemented prosthesis. 21 CFR §888.3390<br><br>Hip joint metal/polymer constrained cemented or<br>uncemented prosthesis. 21 CFR §888.3310<br><br>Hip joint femoral (hemi-hip) metallic cemented or<br>uncemented prosthesis. 21 CFR §888.3360 | |
| Regulatory Class: | Class II | |
| Product Codes: | 87 MEH - prosthesis, hip, semi-constrained, uncemented,<br>metal/polymer, non-porous, calcium-phosphate<br><br>87 LZO - prosthesis, hip, semi-constrained,<br>metal/ceramic/polymer, cemented or non-porous,<br>uncemented<br><br>87 LPH - prosthesis, hip, semi-constrained,<br>metal/polymer, porous uncemented<br><br>87 JDI - prosthesis, hip, semi-constrained,<br>metal/polymer, cemented<br><br>87 KWY - prosthesis, hip, hemi-, femoral,<br>metal/polymer, cemented or uncemented<br><br>87 KWZ - prosthesis, hip, constrained, cemented or<br>uncemented, metal/polymer<br><br>87 KWL - prosthesis, hip, hemi-, femoral, metal | |

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(K092406 pg 2/3)

87 LWJ - prosthesis. hip. semi-constrained. metal/polymer, uncemented

For Information contact:

Estela Celi, Regulatory Affairs Associate Howmedica Osteonics Corp. 325 Corporate Drive Mahwah. NJ 07430 Phone: [phone] Fax: [phone]

Date Prepared:

. August 8, 2009

## Description:

Howmedica Osteonics is introducing a modular hip prosthesis. The basic design of the ABG™ II Modular Hip Stem, referred as the ABG™ II Modular, is similar to other total hip systems commercially distributed such as the Stryker Modular Hip System.

The subject hip stem is composed of a modular stem with a modular neck intended for cementless, press-fit application. It is designed for use with the currently available compatible Howmedica Osteonics' femoral heads, bipolars and their compatible acetabular components.

#### Intended Use:

The ABG™ II Modular Hip Stem is a sterile, single-use device intended for use in primary and revision total hip arthroplasty to alleviate pain and restore function. This device is intended to be used with any currently available compatible Howmedica Osteonics' acetabular components. Compatibility with the modular stems includes: V40 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40 CoCr Heads, V40 LFIT CoCr Heads, C-Taper Alumina Heads when used with the V40/C-taper Adaptor, C-Taper Delta Heads when used with C-taper Adaptor, UHR Universal Head, Unitrax Heads when used with the Unitrax V40 Modular Adapter.

## Indications:

The indications for use of total hip replacement prostheses include:

- Noninflammatory degenerative ioint disease including osteoarthritis and avascular 1) necrosis;
- Rheumatoid arthritis; 2)
- 3) Correction of functional deformity:
- Revision procedures where other treatments or devices have failed; and, 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur ર) with head involvement that is unmanageable using other techniques.

Stryker's ABGTM II Modular Hip Stem is intended for cementless use only.

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(K092406 pg 3/3)

7

## Substantial Equivalence:

The ABG™ II Modular Hip Stem, referred to as ABG™ II Modular, is substantially equivalent to other commercially available hip stems in regard to intended use, design materials and operational principles as a hip prosthesis. The following devices are examples of predicate systems; Stryker Modular Hip System and Rejuvenate Monolithic Hip Size 4 Stem. Based upon the mechanical testing the ABG™ II Modular Hip Stem is substantially equivalent for its intended use to other press-fit femoral replacement hip stems currently on the market.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird's head and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Howmedica Osteonics Corp % Estela Celi 325 Corporate Drive Mahwah, New Jersey 07430

NOV - 4 2009

Re: K092406 Trade/Device Name: ABG II Modular Hip Stem Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: MEH, LZO, LPH, JDI, KWY, KWZ, KWL, LWJ Dated: August 3, 2009 Received: August 6, 2009

Dear Ms. Celi:

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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Ms. Estela Celi

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nil R.S. Oplen

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): KC92406(pg. 1/1)

Device Name: ABG™ II Modular Hip Stem

Indications for Use:

The indications for use of the total hip replacement prostheses include:

- Noninflammatory degenerative joint disease including osteoarthritis and avascular 1) necrosis;
- Rheumatoid arthritis 2)
- Correction of functional deformity; 3)
- Revision procedures where other treatments or devices have failed; and, 4)
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur 5) with head involvement that are unmanageable using other techniques.

· Stryker's ABG™ II Modular Hip Stem is intended for cementless use only.

Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Santa for mxm

Wision Sign-Q Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092406