PIPELINE TOTAL HIP SYSTEM

K131237 · Pipeline Orthopedics · LPH · Jun 13, 2013 · Orthopedic

Device Facts

• Record ID: K131237
• Device Name: PIPELINE TOTAL HIP SYSTEM
• Applicant: Pipeline Orthopedics
• Product Code: LPH · Orthopedic
• Decision Date: Jun 13, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3358
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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 Tapered Hip Stem and PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured (PST™) surface provides biological fixation when used in a cementless application. The Pipeline Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

Device Story

Pipeline Total Hip System line extension; adds HA-coated acetabular shells, Biolox® delta ceramic femoral heads, 40mm CoCr femoral heads, and 40mm Vitamin E UHMWPE liners. Components provide structural support and articulation for total hip arthroplasty. Used in surgical settings by orthopedic surgeons. Components integrate with existing Pipeline Total Hip System (K112802) to restore joint function and alleviate pain in patients with degenerative or traumatic hip conditions. Biological fixation achieved via porous structured (PST™) surfaces and HA coating in cementless applications.

Clinical Evidence

No clinical data. Substantial equivalence is based on identical design, materials, and manufacturing to the predicate device (K122158).

Technological Characteristics

System includes HA-coated acetabular shells, Biolox® delta ceramic femoral heads, CoCr femoral heads, and Vitamin E-stabilized UHMWPE liners. Features porous structured (PST™) surfaces for biological fixation. Designed for cementless or cemented application. Components are identical to those in K122158.

Indications for Use

Indicated for skeletally mature patients 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 (reconstruction, fixation, arthrodesis, hemiarthroplasty, surface replacement).

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 (K122158)

Submission Summary (Full Text)

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## K131237 Page 1/2

## Pipeline Total Hip System – Line Extension

## Special 510(k) Premarket Application

#### 7 510(k) Summary

# JUN 1 3 2013

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

| Device Name and Classification | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Pipeline Total Hip System - Line Extension |
| Device Common Name: | Artificial Total Hip Replacement |
| Regulation Number and Description: | 888.3358 - Hip joint metal/polymer/metal semi-<br>constrained porous-coated uncemented prosthesis |
| Device Class: | II |
| Product Codes: | LPH - prosthesis, hip, semi-constrained,<br>metal/polymer, porous uncemented |
| | JDI - prosthesis, hip, semi-constrained,<br>metal/polymer, cemented |
| | OQG - hip prosthesis, semi-constrained, cemented,<br>metal/polymer, + additive, porous, uncemented |
| | OQH - hip, semi-constrained, cemented,<br>metal/polymer + additive, cemented |
| | LZO (Hip joint metal/ceramic/polymer semi-<br>constrained cemented or nonporous uncemented<br>prosthesis) |
| | OQI (hip, semi-constrained, cemented,<br>metal/ceramic/polymer + additive, porous<br>uncemented) |
| | MEH (prosthesis, hip, semi-constrained,<br>uncemented, metal/polymer, non-porous, calcium-<br>phosphate) |
| Advisory Panel: | Orthopedic |
| Address and Registration: | |

| Submitter's Name: | Pipeline Orthopedics |
|------------------------------------|-----------------------------------------------|
| Address: | 3 Wing Drive Suite 102 Cedar Knolls, NJ 07927 |
| Contact Person: | Robert C. Cohen |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date Summary Prepared: | April 30, 2013 |
| Establishment Registration Number: | 3009701876 |

## Purpose of Submission

This Special 510(k) addresses an administrative line extension to the Pipeline Total Hip System (510(k) #K112802), and introduces hip system components that have already been determined substantially equivalent by FDA in 510(k) #K122158 for the designated indications for use under the name of the holding company's other subsidiary.

Page 11 of 29

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

The subject HA-coated Acetabular Shells, Biolox® delta Ceramic Femoral Heads, 40mm CoCr Femoral Heads, and corresponding 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Liners submitted in this 510(k) under the name of Pipeline Biomedical Holdings' subsidiary, Pipeline Orthopedics, are identical, and therefore substantially equivalent to, the same devices cleared under the name of Pipeline Biomedical Holdings' subsidiary, Pipeline Biomedical Products, in predicate 510(k) number K122158.

### Device Description

This 510(k) addresses the addition of the following components (already cleared under 510(k) #K122158) to the Pipeline Total Hip System:

- . HA-coated Acetabular Shells feature a thin HA coating applied over the porous structured (PST) shells in a range of sizes,
- . Biolox® delta Ceramic Femoral Heads available in a range of diameters and extension options,
- . 40mm CoCr Femoral Heads, and
- . 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Acetabular Liners.

These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K112802 and as the PBP Total Hip System in 510(k) #K122158.

#### Intended Use

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

The Pipeline Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

#### Comparison of Technological Characteristics

The HA-coated Acetabular Shells, Biolox® delta Ceramic Femoral Heads, 40mm CoCr Femoral Heads, and 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Acetabular Liners are identical to the same components determined substantially equivalent in predicate 510(k) #K122158 in all respects except for the Pipeline Biomedical Holdings subsidiary name assigned to the 510(k). There is no difference in intended use, materials, design features, component sizing, or manufacturing methods.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

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

June 13, 2013

Pipeline Orthopedics % M Squared Associates, Incorporated Ms. Terry Sheridan Powell Senior Project Manager 901 King Street, Suite 101 Alexandria, Virginia 22314

Re: K131237

Trade/Device Name: Pipeline Total Hip 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, JDI, OQG, OQH, LZO, OQI, MEH Dated: May 14, 2013 Received: May 15, 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-Drugand 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 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

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## Page 2 - Ms. Terry Sheridan Powell

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 (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.

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" (21 CFR 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, |
|--|------------------|
|--|------------------|

Erin Keith
For

| | Mark N. Melkerson |
|--|--------------------------------|
| | Director |
| | Division of Orthopedic Devices |
| | Office of Device Evaluation |
| | Center for Devices and |
| | Radiological Health |

Enclosure

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#### Indication for Use Statement e

510(k) Number (if known): K_131237to be assigned

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

The Pipeline Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

AND/OR Prescription Use __ X (Part 21 CFR 801 Subpart D)

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)

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Division of Orthopedic Devices

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