Trident II Acetabular System

K191358 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · LPH · Oct 24, 2019 · Orthopedic

Device Facts

• Record ID: K191358
• Device Name: Trident II Acetabular System
• Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
• Product Code: LPH · Orthopedic
• Decision Date: Oct 24, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.

Device Story

Trident® II Acetabular System comprises acetabular shells, 6.5mm low-profile hex screws, and dome hole plugs; intended for cementless fixation into prepared acetabulum during primary or revision total hip arthroplasty. System integrates with existing Trident® polyethylene inserts, MDM® liners, and constrained acetabular inserts. Devices are sterile, single-use implants. Surgeons utilize system to restore hip joint function in patients with degenerative disease or fracture. Output is mechanical stabilization of the hip joint; clinical benefit includes pain relief, improved mobility, and reduced dislocation risk in high-risk patients.

Clinical Evidence

No clinical data. Bench testing only; equivalence demonstrated via dimensional analysis and MR evaluation. Bacterial endotoxin testing referenced ANSI/AAMI ST72:2011 with limit < 20EU/Device.

Technological Characteristics

Cementless acetabular prosthesis components including shells, screws, and dome hole plugs. Sterile, single-use. Materials and design consistent with predicate systems. Endotoxin limit < 20EU/Device per ANSI/AAMI ST72:2011.

Indications for Use

Indicated for patients with painful, disabling hip joint disease (degenerative/rheumatoid/posttraumatic arthritis, late-stage avascular necrosis), revision of failed femoral head replacement/cup arthroplasty, clinical management problems where arthrodesis/other techniques are less likely to succeed, or poor/inadequate bone stock. MDM® liners indicated for nonunion, femoral neck/trochanteric fractures, and dislocation risks. Constrained liners indicated for primary/revision patients at high risk of dislocation due to prior history, bone loss, laxity, neuromuscular disease, or intraoperative instability.

Regulatory Classification

Identification

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

Predicate Devices

• Trident® II Acetabular System (K171768)
• Acetabular Dome Hole Plugs (K942809)

Reference Devices

• Osteonics Secur-Fit HA Generation II [aka Trident® PSL] Acetabular Shells (K983382, K143085)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Howmedica Osteonics Corp. aka Stryker Orthopaedics Valerie Giambanco Senior Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

### Re: K191358

Trade/Device Name: Trident II Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, KWZ, LZO, JDI, MEH Dated: September 24, 2019 Received: September 26, 2019

October 24, 2019

Dear Valerie Giambanco:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191358

Device Name Trident® II Acetabular System

Indications for Use (Describe)

Indications for Use

· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatic arthritis or late stage avascular necrosis.

- · Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
· Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.

· Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM® Liners

· Treatment of nonumion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

• Dislocation risks

When used with Constrained Liner

• The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Trident® II Acetabular Shells are indicated for cementless use only.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|--|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |

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# 510(k) Summary of Safety and Effectiveness: Trident® II Acetabular System

| Sponsor | Stryker Orthopaedics<br>325 Corporate Drive<br>Mahwah, NJ 07430 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Valerie Giambanco<br>Principal Regulatory Affairs Specialist<br>Stryker Orthopaedics<br>[e-mail]<br>Ph: 201-831-6275 |
| Date Prepared: | Sept 24, 2019 |
| Proprietary Name: | Trident® II Acetabular System<br>Total Hip Joint Replacement |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis. (888.3358)<br>Hip joint metal/polymer constrained cemented or uncemented<br>prosthesis. (888.3310)<br>Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis (888.3353)<br>Hip joint metal/polymer semi-constrained cemented prosthesis<br>(888.3350) |

Product Codes: LPH, KWZ, LZO, JDI, MEH

# Legally Marketed Predicate Devices to Which Substantial Equivalence is Claimed:

- Trident® II Acetabular System (K171768) ●

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- Acetabular Dome Hole Plugs (K942809) .
# Reference Devices Supporting Substantial Equivalence:

- . Osteonics Secur-Fit HA Generation II [aka Trident® PSL] Acetabular Shells (K983382, K143085)
## Device Description:

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and dome hole plugs are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident® Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments. The purpose of this Special 510(k) is to add an additional dome hole plug option for use with the Trident® II Acetabular System.

### Intended Use:

The subject Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.

#### Indications:

The subject Trident® II Acetabular System maintains the same indications for use as those cleared in K171768.

### Indications for Use:

· Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.

• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.

· Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.

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• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

#### When used with MDM® Liners:

• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

• Dislocation risks

## When used with Constrained Liners:

• The Trident® Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Trident® II Acetabular Shells are indicated for cementless use only.

Summary of Technological Characteristics: Device comparisons and performance testing show that the Trident® II Acetabular System when used with the Acetabular Dome Hole Plug is substantially equivalent to the predicates in terms of intended use, indications, design, materials, performance characteristics and operational principles.

Non-Clinical Testing: No new non-clinical testing was performed. Analyses have demonstrated equivalence in dimensions and MR evaluation. Prior bacterial endotoxin testing (BET) as specified in ANSI/AAMI ST72:2011 was referenced for pyrogenicity testing to achieve an Endotoxin limit of < 20EU/Device.

Conclusion: Based upon a comparison of intended use, materials, technological characteristics, and tolerance and MR analysis, the Trident® II Acetabular System when used with the Acetabular Dome Hole Plug is substantially equivalent to the predicate devices identified in this premarket notification.