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 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.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Application for a line extension to the "Pipeline Total Hip System." This type of submission claims substantial equivalence to previously cleared devices. Therefore, the "acceptance criteria" and "study" described are not for a de novo device, but rather the justification for substantial equivalence.

Here's how the information aligns with your request:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) is substantial equivalence to predicate devices. The reported "performance" is that the new components are identical to those already cleared.

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate K122158	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 cleared under 510(k) #K122158.
No difference in key characteristics	There is no difference in intended use, materials, design features, component sizing, or manufacturing methods compared to the predicate devices cleared in K122158. The only difference is the subsidiary name under which they are marketed.
Compatibility with existing system	The new components are compatible with the Pipeline Total Hip System (cleared in K112802) and the PBP Total Hip System (cleared in K122158).
Indicated Use Match	The intended use for the line extension components matches the intended use of the Pipeline Total Hip System, which includes conditions like osteoarthritis, traumatic arthritis, avascular necrosis, congenital hip dysplasia, acute traumatic fracture, and failed previous hip surgeries.

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a "test set" in the traditional sense of clinical or performance data for a new device. Instead, the "test" is a comparison to existing, cleared devices on the market. The submission asserts that the components are identical to those previously cleared. Therefore, there's no independent sample size or data provenance to report for a specific "test set." The "provenance" for the predicate devices would be based on the information provided in their respective 510(k) submissions (K112802 and K122158), which is not detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a claim of identicality to cleared devices, not a study requiring expert-established ground truth for a new device's performance. The "ground truth" here is the prior FDA clearance of the identical components.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in this type of submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical hip replacement system, not an AI-assisted diagnostic or imaging tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical hip replacement system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the prior FDA clearance and determination of substantial equivalence for the identical components under 510(k) #K122158. The submission argues that since the new components are identical to those previously cleared, their safety and effectiveness are established by the predicate's clearance.

8. The Sample Size for the Training Set

Not applicable, as this is a mechanical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this is a mechanical device, not a machine learning algorithm.

Summary

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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-constrained porous-coated uncemented prosthesis
Device Class:	II
Product Codes:	LPH - prosthesis, hip, semi-constrained,metal/polymer, porous uncemented
	JDI - prosthesis, hip, semi-constrained,metal/polymer, cemented
	OQG - hip prosthesis, semi-constrained, cemented,metal/polymer, + additive, porous, uncemented
	OQH - hip, semi-constrained, cemented,metal/polymer + additive, cemented
	LZO (Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncementedprosthesis)
	OQI (hip, semi-constrained, cemented,metal/ceramic/polymer + additive, porousuncemented)
	MEH (prosthesis, hip, semi-constrained,uncemented, metal/polymer, non-porous, calcium-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:	(973) 267-8800
Fax Number:	(973) 267-8810
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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)

Elizabethịﻙ http://rank.-S

Division of Orthopedic Devices

Page 1 of __ 1_

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
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.(b)
Classification. Class II.