K Number
K141377
Device Name
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
Date Cleared
2014-11-21

(178 days)

Product Code
Regulation Number
888.3353
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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.
More Information

Not Found

No
The summary describes a mechanical hip implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.

Yes.
The device is intended for use in total hip arthroplasty to treat severe hip pain and disability, correct functional deformity, and address various hip conditions, which falls under the definition of a therapeutic device designed to cure, mitigate, treat, or prevent disease.

No

Explanation: The provided text describes the IntraBlock™ BioBall™ Hip System (IBS) as a device intended for total hip arthroplasty, composed of various components for surgical implantation. Its purpose is to treat severe hip pain and disability, correct deformities, and treat fractures, not to diagnose medical conditions.

No

The device description clearly states it is composed of physical components like femoral stems, heads, taper adapter sleeves, and acetabulum cups, which are hardware.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the IntraBlock™ BioBall™ Hip System is for use in total hip arthroplasty. This is a surgical procedure to replace a damaged hip joint.
  • Device Description: The device is described as a system of physical components (femoral stems, heads, taper adapter sleeves, and acetabulum cups) made of materials like ceramic and titanium alloy. These are implantable medical devices used in surgery.
  • IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.

The IntraBlock™ BioBall™ Hip System is a surgical implant, not a diagnostic test performed on bodily samples.

N/A

Intended Use / Indications for Use

The IntraBlockTM BioBallTM 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.

Product codes (comma separated list FDA assigned to the subject device)

LZO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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 2014
Merete Medical GmbH
Alt Lankwitz 102
12247 Berlin, Germany |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Registration Number: 3002949614 | |
| Contact Person: | Emmanuel Anapliotis
Merete Medical GmbH
Alt-Lankwitz 102
12247 Berlin, Germany
Phone: 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 Heads
K001534 - Pinnacle™ Acetabular Cup
K000306 - Pinnacle™ Acetabular Cup
K093472 - Trinity Acetabular System |

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.

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.