PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)

K130353 · Pipeline Orthopedics · LPH · Jul 1, 2013 · Orthopedic

Device Facts

• Record ID: K130353
• Device Name: PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION)
• Applicant: Pipeline Orthopedics
• Product Code: LPH · Orthopedic
• Decision Date: Jul 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PIPELINE Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to: - A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia: - Acute traumatic fracture of the femoral head or neck; - Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement. The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application. The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

Device Story

Artificial hip replacement system components; includes femoral stems, femoral heads, acetabular shells, liners, bone screws, and dome hole covers. Line extension adds smaller size 1 femoral stem, tantalum beads for radiostereometric analysis (RSA) of implant migration, and acetabular screw hole occluders. Used by orthopedic surgeons in clinical settings for total hip arthroplasty. Provides biological fixation via porous structured surface (PST™) or hydroxyapatite (HA) coating. Tantalum beads allow post-operative monitoring of implant stability via radiographic imaging. Benefits patients by restoring joint function and reducing pain associated with degenerative or traumatic hip conditions.

Clinical Evidence

Bench testing only. Fatigue testing performed on worst-case (smallest) hip stem per ISO 7206-4:2010 and neck fatigue testing per ISO 7206-6:1992 and ASTM F2068-03. Engineering analysis conducted for plasma spray coating distal boundary.

Technological Characteristics

Materials: titanium alloy, CP titanium, cobalt chromium, alumina ceramic, ultrahigh molecular weight polyethylene (standard/highly crosslinked Vitamin E), tantalum beads. Fixation: cementless or cemented; porous structured technology (PST™) and HA coating. Standards: ISO 7206-4:2010, ISO 7206-6:1992, ASTM F2068-03. Sterilization: same processes as predicate devices.

Indications for Use

Indicated for skeletally mature individuals requiring total hip replacement due to osteoarthritis, traumatic/rheumatoid arthritis, avascular necrosis, congenital hip dysplasia, acute traumatic femoral head/neck fracture, or failed previous hip surgery.

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

• Pipeline Total Hip System (K112802)
• PBP Total Hip System (K122802)
• Synergy Hip System (K061066)
• Trident Screw Hole Plugs (K022799)

Submission Summary (Full Text)

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## 510(k) Summary

# JUL 0 1 2013

The following 510k Summary is provided in accordance with the requirements of 21 CFR 807.92.

## 1.1. Device Name and Classification

Device Trade Name: Device Common Name:

Requlation Number and Description:

Device Class: Product Codes:

Pipeline Total Hip System Artificial Total Hip Replacement System Components 888.3358 - Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis = LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented JD! - prosthesis, hip, semi-constrained,

metal/polymer, cemented Orthopedic

Advisory Panel:

## 1.2. Address and Registration

Submitter's Name: Address:

Contact Person: Telephone Number: Fax Number: Date Summary Prepared:

Establishment Registration Number: 3009701876

Pipeline Biomedical Products, LLC 3 Wing Drive Suite 102 Cedar Knolls, NJ 07927 Robert C. Cohen [phone] [phone] February 11, 2013

#### Identification of Legally Marketed Device to which Submitter 1.3. Claims Equivalence

The subject Pipeline Total Hip System Line Extension is substantially equivalent to the predicate devices shown in the following table.

| Device Name | Company | 510(k)<br>Number | Clearance<br>Date |
|---------------------------|--------------------------------------------------------------|------------------|-------------------|
| Pipeline Total Hip System | Pipeline Orthopedics | K112802 | 3/9/2012 |
| PBP Total Hip System | Pipeline Biomedical Products | K122802 | 12/11/2012 |
| Synergy Hip System | Smith & Nephew Orthopedics | K061066 | 7/14/2006 |
| Trident Screw Hole Plugs | Stryker Orthopaedics (formerly<br>Howmedica Osteonics Corp.) | K022799 | 11/21/2002 |

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## 1.4. Device Description

The predicate Pipeline Total Hip System (K112802) and PBP Total Hip System (K122802) are artificial hip replacement systems that include femoral stems (titanium alloy and CP titanium), femoral heads (cobalt chromium or alumina ceramic), acetabular shells (titanium alloy, porous structured technology (PST™)), acetabular liners (ultrahigh molecular weight polyethylene, standard and highly crosslinked Vitamin E), acetabular bone screws (titanium alloy) and dome hole covers (titanium alloy) for the holes in the acetabular shells. This subject 510k adds the following components to the existina hip systems:

- A smaller, size 1 femoral stem; .
- The option of hip stems (all sizes) with 3 tantalum beads, to allow the surgeon to . perform radiostereometric analysis(RSA) to measure implant migration; and
- . The option of acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.

## 1.5. Intended Use

-

PIPELINE Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia:
- -Acute traumatic fracture of the femoral head or neck;
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

#### Comparison of Technological Characteristics 1.6.

The Pipeline Total Hip System described in this 510k has the same indications for use as the predicate Pipeline Total Hip System. The additional Pipeline Total Hip System components described in this 510k have similar designs to one or more of the identified predicate devices, and are manufactured from the same materials as one or more of the predicate device systems, and/or from materials that comply with recognized implantable materials standards. The components are packaged and sterilized using the

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same processes as one or more of the predicate devices. The subject Pipeline Total Hip System components are therefore substantially equivalent to the predicates based on comparisons of intended use, design features and technological characteristics, materials, and sterilization/packaging methods.

## 1.7. Performance Testing

The following performance tests and engineering analyses were provided to demonstrate substantial equivalence:

- Hip Stem Fatique Testing was conducted for the worst case (smallest) hip stem . according to the method described in ISO 7206-4:2010, Implants for surgery-Partial and total hip joint prostheses, Determination of Endurance Properties and Performance of Stemmed Femoral Components, and Engineering Analysis was conducted to determine satisfactory distal boundary for the plasma spray coating.
- Stem Neck Fatigue Testing of the worst-case size was conducted according to . the methods described in ISO 7206-6:1992 Implants for surgery-Partial and total hip joint prostheses-Part 6 and ASTM F2068-03 Standard Specification for Femoral Prostheses - Metallic Implants.

## 1.8. Conclusions

The subject Pipeline Total Hip System components share indications for use as the predicate Pipeline hip system, and a comparison of technological characteristics supported by performance testing demonstrates the Substantial Equivalence of the subject Pipeline Total Hip System components to one or more of the identified predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### July 1, 2013

Pipeline Orthopedics % M Squared Associates, Incorporated Ms. Terry Powell Senior Project Manager 901 King Street, Suite 102 Alexandria, Virginia 22314

Re: K130353

Trade/Device Name: Pipeline Total Hip System - Line Extension 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, JDI Dated: May 30, 2013 Received: June 3, 2013

Dear Ms. Powell:

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. Please note: CDRH does not evaluate information related to contract fiability 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

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#### Page 2 - Ms. Terry. Powell

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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.

# Erin ith

For

Mark Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

### 510(k) Number (if known): K130353

Device Name: Pipeline Total Hip System - Line Extension

#### Indications for Use:

-

t

PIPELINE Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

- . A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dvsplasia:
- Acute traumatic fracture of the femoral head or neck;
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elizabeth L. Frank -S

Division of Orthopedic Devices

Page 1 of 1

K130353, Al Response, Exhibit 1