(182 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of the hip implant components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, the IntraBlock™ BioBall™ Hip System, is intended for total hip arthroplasty to alleviate severe hip pain and disability, correct functional deformity, treat fractures, and revise failed treatments or devices. These uses clearly fall under the definition of therapeutic interventions as they aim to treat a disease, restore function, or alleviate symptoms.
No
The device description clearly states it is a hip system composed of femoral stems, heads, taper adapter sleeves, and acetabulum cups, intended for use in total hip arthroplasty (replacement surgery). It is a prosthetic implant, not a tool for diagnosis.
No
The device description clearly outlines physical components made of titanium alloy and ceramic, which are hardware. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states the device is for "total hip arthroplasty" and lists conditions related to hip pain, disability, and bone issues. This describes a surgical implant used to replace a damaged hip joint.
- Device Description: The description details the components of a hip replacement system (femoral stems, heads, cups, etc.) and their materials. This aligns with a surgical implant, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the IntraBlock™ BioBall™ Hip System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 l 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
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 IBS stem is straight, collarless, and flat with a tapered design. The stem is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a proximal titanium plasma spray (TPS) coating. The stems are proportionally sized and shaped in sizes 6.25 mm to 15.00 mm to match the geometry of the femur. A lateralized version of the device is available. Both versions have a neck shaft angle of 135° and a 12/14 morse taper trunion. The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameter 28 mm. The taper adapter sleeves are made from titanium alloy (Ti-6AI-4V ELI) with a 12/14 morse taper trunion in the four neck lengths S, M, L and XL. 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 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 48mm up to 62mm 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
Non-clinical testing and analysis were provided, including mechanical testing and coating characterization. Mechanical testing included distal and proximal fatique testing of the worst case consistent with the "Guidance for Industry and FDA staff Non-Clinical Information for femoral Stem Prostheses". Range of Motion analysis was also performed. The TPS coating underwent characterization per FDA´s .Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants to support reconsideration of Post Market Surveillance Requirements". The Modular connection analysis including fretting and corrosion were also performed as well as static compression 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.
Key Metrics
Not Found
Predicate Device(s)
K073567, K043537, K121563, K001534, K000306, K093472
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 2 4 2013
2. 510(k) Summary of Safety and Effectiveness Information
| Date Prepared: | November 2012 |
|---|---|
| Submitted by: | Merete Medical GmbH |
| Alt Lankwitz 102 | |
| 12247 Berlin, Germany |
FDA Registration Number: 3002949614
Contact Person:
:: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
Rüdiger Hilken Merete Medical, Inc. 4 Crotty Lane - Suite 118 New York International Plaza New Windsor, NY 12553 Phone: 914 967 1532
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
K073567 - Biolox® delta Option Ceramic Heads Predicate Devices: K043537 - Taperloc® 12/14 Taper Femoral Components K121563 - Corin Trift TS Hip 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 IBS stem is straight, collarless, and flat with a tapered design. The stem is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a proximal titanium plasma spray (TPS) coating. The stems are proportionally sized and shaped in sizes 6.25 mm to 15.00 mm to match the geometry of the femur. A lateralized version of the device is available. Both versions have a neck shaft angle of 135° and a 12/14 morse taper trunion. The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameter 28 mm.
The taper adapter sleeves are made from titanium alloy (Ti-6AI-4V ELI) with a 12/14 morse taper trunion in the four neck lengths S, M, L and XL.
Merete Medical GmbH
Submission Date: 2012-11-16 Rev. 2: 2013-04-18_Rev.3: 2013-05-17
1
510(k) Submission - IntraBlock™ BioBall™ Hip System (IBS)
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 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 48mm up to 62mm outer diameter.
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 l 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 ﺳ
The IBS is indicated for cementless use only.
Substantial Equivalence:
The IntraBlock™ BioBall™ Stems, MultiCup™ Locking PressFit, Femoral Heads and Titanium Taper Adapter Sleeves are technologically similar to the predicate devices.
Legally marketed Devices to which substantial Equivalence is claimed
K073567 - Biolox® delta Option Ceramic Heads
K043537 - Taperioc® 12/14 Taper Femoral Components
K000306 - Pinnacle™ Acetabular Cup
K093472 - Trinity Acetabular System
Non-Clinical Performance Data:
Non-clinical testing and analysis were provided, including mechanical testing and coating characterization. Mechanical testing included distal and proximal fatique testing of the worst case consistent with the "Guidance for Industry and FDA staff Non-Clinical Information for femoral Stem Prostheses". Range of Motion analysis was also performed. The TPS coating underwent characterization per FDA´s .Guidance for Industry on Testing of Metallic Plasma Sprayed Coatings on Orthopaedic Implants to support reconsideration of Post Market Surveillance Requirements". The Modular connection analysis including fretting and corrosion were also performed as well as static compression 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.
Merete Medical GmbH
Submission Date: 2012-11-16 Rev. 2: 2013-04-18 Rev.3: 2013-05-17
Page 15 of 75
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2013
Merete Medical GmbH % Mr. Emanuel Anapliotis President Alt-Lankwitz 102 Berlin 12247 Germany
Re: K123619
Trade/Device Name: IntraBlock™ BioBall™ 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: April 18, 2013 Received: April 24, 2013
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
3
Page 2 - Mr. Emanuel 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 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/Resourcesfor You/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/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,
Image /page/3/Picture/8 description: The image shows the name "Erin DKeith" in a bold, sans-serif font. The letters "E", "r", "i", "n", "e", "i", "t", and "h" are solid black, while the letters "D" and "K" have a patterned design. The name appears to be a logo or a stylized signature.
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1. Indications for Use Statement
Indications for Use
510(k)·Number (if known): K123619
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. ー
- -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. -
AND/OR
The IBS is indicated for cementless use only.
Prescription Use
(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)
Elizabeth Frank -S
Division of Orthopedic Devices
Merete Medical GmbH
Submission Date: 2012-11-16 Rev. 2: 2013-04-18_Rev.3: 2013-05-17
Page 13 of 75