TRIDENT ALL POLY CUP

K012026 · Howmedica Osteonics Corp. · JDI · Jul 18, 2001 · Orthopedic

Device Facts

• Record ID: K012026
• Device Name: TRIDENT ALL POLY CUP
• Applicant: Howmedica Osteonics Corp.
• Product Code: JDI · Orthopedic
• Decision Date: Jul 18, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trident™ All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.

Device Story

Trident® All Poly Cup is a polyethylene acetabular component for primary or revision total hip arthroplasty; cemented into acetabulum; used with Howmedica Osteonics femoral heads. Device modification involves changing radiographic marker material from cobalt chromium alloy to tantalum. Device manufactured from Crossfire™ UHMWPE. Used by orthopedic surgeons in clinical/surgical settings. Provides bearing surface for hip joint replacement; tantalum marker allows radiographic visualization for post-operative assessment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polyethylene acetabular cup; UHMWPE material (ASTM F-648); tantalum bead radiographic marker (ASTM F-560). Cemented fixation. No software or electronic components.

Indications for Use

Indicated for patients undergoing primary or revision total hip arthroplasty requiring a cemented polyethylene acetabular component. Compatible with Howmedica Osteonics' femoral heads.

Regulatory Classification

Identification

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Trident® All Poly Cup (K001956)
• Trident® All Poly Cup (K010310)
• Tantalum Bead Radiographic Marker (K010348)

Submission Summary (Full Text)

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## JUL 1 8 2001

012026 p1/2

Special 510(k) Summary - Device Modification for the Trident® All Poly Cup

| Proprietary Name: | Trident® All Poly Cup |
|------------------------------------|----------------------------------------------------------------------------------|
| Common Name: | All Polyethylene Acetabular Cup |
| Classification Name and Reference: | 21 CFR §888.3350<br>Hip joint metal/polymer semi-constrained cemented prosthesis |
| Proposed Regulatory Class: | II |
| Device Product Code: | 87 JDI<br>Prosthesis, hip, semi-constrained, metal/polymer, cemented |

For Information contact:

ﮐﮯ ﻧ

Jennifer A. Daudelin, Regulatory Affairs Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 [phone] Fax: [phone] Email: [e-mail]

This Special 510(k) submission is intended to address a material modification to the radiographic marker of the Trident® All Poly Cup. The prodicate Trident® All Poly Cup was found substantially equivalent via the 510(k) process in 510(k)s #K001956 and #K010310. The predicate Tantalum Bead Radiographic Marker was found substantially equivalent via 510(k) #K010348. The design, manufacturing mothods, intended use, packaging and sterilization of the subject device are identical to those of predicate Trident® All Poly Cup .

The subject Trident® All Poly Cups are polyethylene acetabular components that are intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. The subject device is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.

The subject Trident® All Poly Cup is available in Crossfire™ UHMWPE with a tantalum bead radiographic marker. The predicate device is also manufactured from Crossfire™ UHMWPE;

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The Crossfire™ however, the radiographic marker is a cobalt chromium alloy bead. UHMWPE material conforms to ASTM F-648. The radiographic marker of the subject device complies with ASTM standard F-560 while the radiographic marker for the predicate device conforms to ASTM F-1377.

K012026

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2001

Ms. Jennifer A. Daudelin Regulatory Affairs Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K012026

Trade/Device Name: Trident® All-Poly Cup Regulation Number: 888.3350 Regulatory Class: II Product Code: JDI Dated: June 27, 2001 Received: June 28, 2001

Dear Ms. Daudelin:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 5 rotty notification of the indications for use in interests a gommerce above and we nave determined the devices marketed predicate devices marketed in interstate on to devices th stated in the enclosure) to legally markets preceded bevice Amendments, or to devices that prior to May 26, 1970, the chaouncent and the provisions of the Federal Food, Drug, and have been reclassified in accordance with the people, subject to the general controls Cosmetic Act (Act). Tou may, merciols, mance the Act include requirements for annual provisions of the Act. "The general controls provisions of assisted as and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (Scc abovo) this cuch additional controls. Existing major regulations
(Premarket Approval), it may be subject to such additions, Title 21, Ports (Premarket Approval), it may of subject to atential Regulations, Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, affecting your de rioe car or reamination assumes compliance with the Current Good A substantially equirements, as set forth in the Quality System Regulation (OS) for for Manufacturing Fractive requirencina (21 CFR Part 820) and that, through periodic QS Medical Devices. General regulation (FDA) will verify such assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify such assumplia mspections, the rood and Drug Nammount in regulatory action. In addition, FDA may publish comply with the GMI Tegatiation may rederal Register. Please note: this further announcenting your devros submission does not affect any obligation your might.
response to your premarket notification submission does not affect any of any and st response to your prematics notheater should be the Act for devices under the Electronic Product nave under soctions 551 times, or other Federal laws or regulations.

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Page 2 - Ms. Jennifer A. Daudelin

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 nredicate 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Bmt dulle rwo for

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

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: Trident® All Poly Cup

Indications for Use:

The Trident™ All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is obesigned to be cemented into the acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |
| | (Division Sign-Off) | <p>Bmhblellono for cmu</p> |
| | Division of General, Restorative and Neurological Devices | |
| | 510(k) Number K012026 | |