Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis,
Avascular necrosis of the femoral head, -
= Correction of functional deformity,
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques,
-Revision procedures where other treatment or devices have failed.

The IBS is indicated for cementless use only.

Device Description

The IntraBlock™ BioBall™ Hip System (IBS) is composed of femoral stems, heads, taper adapter sleeves and acetabulum cups. The System is designed for uncemented use for either primary or revision hip arthroplasty.

The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameters 28, 32 and 36 mm.

The cementless MultiCup Locking PressFit is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a titanium plasma spray (TPS) coating on the outer surface. It is used with a UHMWPE Inlay sized for Ø28, 32 and 36 mm heads. 5 holes with threaded plugs give the option for an additional fixation with locking screws. The MultiCup is available in 9 different sizes ranged from 46 mm, 48 mm up to 62 mm outer diameter.

AI/ML Overview

The provided document is a 510(k) premarket notification decision letter and summary for a medical device: the IntraBlock™ BioBall™ Hip System (IBS). It focuses on establishing substantial equivalence to previously marketed devices based on non-clinical performance data (mechanical testing and analysis).

Therefore, this document does not contain information about acceptance criteria for a study proving device performance on human subjects, nor does it describe such a study. It describes a regulatory submission for a medical device (a hip replacement system) primarily based on non-clinical (laboratory) testing for mechanical properties and material characteristics to demonstrate substantial equivalence to predicate devices.

Specifically, the document states:

Non-Clinical Performance Data: "Non-clinical testing and analysis were provided to support substantial equivalence. Mechanical testing included testing of the modular connection, wear testing and mechanical testing of the coating as well as coating characterization. Range of Motion analysis also was performed. The modular connection analysis included fretting and corrosion as well as static compression testing (burst testing and post-fatigue burst testing) consistent with the "Guidance document for the preparation of premarket notifications for ceramic ball hip systems". Furthermore the connections between the stem, the adapter and the head, as well as the liner locking mechanism were tested in pull-off, rotation testing and cup/liner disassembly testing."

This clearly indicates a focus on laboratory or bench testing rather than clinical studies involving human subjects or expert assessment of clinical data.

Therefore, I cannot provide the requested information regarding acceptance criteria for a device performance study involving human subjects or expert ground truth, as that information is not present in the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

November 21, 2014

Merete Medical GmbH Emmanuel Anapliotis President Alt-Lankwitz 102 12247 Berlin, Germany

Re: K141377 Trade/Device Name: IntraBlockTM BioBallTM Hip System (IBS) Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint metal/ceramic/polymer semi-constrained, cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO Dated: September 3, 2014 Received: September 8, 2014

Dear Mr. Anapliotis:

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 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 801); medical device reporting (reporting of medical

{1}------------------------------------------------

Page 2 - Mr. Emmanuel Anapliotis

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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

1. Indications for Use Statement

Indications for Use

510(k) Number (if known): K141377

Device Name: IntraBlock™ BioBall™ Hip System (IBS)

Indications for Use:

The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty.

The IBS is indicated for:

Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis,
Avascular necrosis of the femoral head, -
= Correction of functional deformity,
Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques,
-Revision procedures where other treatment or devices have failed.

The IBS is indicated for cementless use only.

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)

{3}------------------------------------------------

510(k) Summary of Safety and Effectiveness Information

Date Prepared:Submitted by:	November 2014Merete Medical GmbHAlt Lankwitz 10212247 Berlin, Germany
FDA Registration Number: 3002949614
Contact Person:	Emmanuel AnapliotisMerete Medical GmbHAlt-Lankwitz 10212247 Berlin, GermanyPhone: 49-30 7799800
Device Name:	IntraBlock™ BioBall™ Hip System (IBS)
Common Name:	Total hip replacement device
Classification Names:	Hip Joint metal/ceramic/polymer semi-constrained,cemented or nonporous uncemented prosthesis(21 CFR 888.3353)
Product Code:	LZO
Proposed Regulatory Class:	Class II
Predicate Devices:	K123619 - IntraBlock™ BioBall™ Hip System (IBS)K073567 - Biolox® delta Option Ceramic HeadsK001534 - Pinnacle™ Acetabular CupK000306 - Pinnacle™ Acetabular CupK093472 - Trinity Acetabular System

Device Description:

The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameters 28, 32 and 36 mm.

{4}------------------------------------------------

Indications for Use

The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty.

The IBS is indicated for:

Patients suffering from severe hip pain and disability due to rheumatoid । arthritis, osteoarthritis, traumatic arthritis
-Avascular necrosis of the femoral head
-Correction of functional deformity
-Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
-Revision procedures where other treatment or devices have failed

The IBS is indicated for cementless use only.

Substantial Equivalence:

The MultiCup™ Locking PressFit Cups and Femoral Heads are technologically similar to the predicate devices.

Legally marketed Devices to which substantial Equivalence is claimed

K123619 - IntraBlock™ BioBall™ Hip System (IBS) K073567 - Biolox® delta Option Ceramic Heads K001534 - Pinnacle™ Acetabular Cup K000306 - Pinnacle™ Acetabular Cup K093472 - Trinity Acetabular System

Non-Clinical Performance Data:

Non-clinical testing and analysis were provided to support substantial equivalence. Mechanical testing included testing of the modular connection, wear testing and mechanical testing of the coating as well as coating characterization. Range of Motion analysis also was performed.

The modular connection analysis included fretting and corrosion as well as static compression testing (burst testing and post-fatigue burst testing) consistent with the "Guidance document for the preparation of premarket notifications for ceramic ball hip systems". Furthermore the connections between the stem, the adapter and the head, as well as the liner locking mechanism were tested in pull-off, rotation testing and cup/liner disassembly testing.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.