K Number
K110542
Device Name
CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
Date Cleared
2011-04-01

(36 days)

Product Code
Regulation Number
888.3358
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications. The general indications for use are: - A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. - C. Proximal femoral fractures. - D. Avascular necrosis of the femoral head. - E. Non-union of proximal femoral neck fractures. - F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities. Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.
Device Description
The Consensus hip systems are semi-constrained, hip prosthesis designed for either The Consensuring bio surgery. They include the Consensus® Hip System (CHS), the Unisyn™ Hip System, and the TaperSet™ Hip System (THS). All three hip systems utilize the exact same 12/14 Morse taper trunnion. These hip stems are compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.
More Information

No
The summary describes a traditional hip prosthesis system and does not mention any AI or ML components or functionalities.

Yes
The device is a total or partial hip arthroplasty system, which is used to treat various painful and debilitating conditions of the hip joint, aiming to restore function and alleviate symptoms. These are therapeutic interventions.

No

The device description indicates that the Consensus hip systems are hip prostheses designed for total or partial hip arthroplasty, which are used for treatment and replacement, not for diagnosing conditions.

No

The device description clearly states it is a hip prosthesis system, which are physical implants, not software. The performance studies also focus on material and mechanical testing of physical components.

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

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description: The provided text describes a hip prosthesis, which is an implantable medical device used to replace a damaged hip joint.
  • Intended Use: The intended use clearly states that the device is for "total or partial hip arthroplasty" and addresses conditions affecting the hip joint itself.
  • No Mention of Specimens: There is no mention of the device being used to test or analyze any biological specimens.

Therefore, based on the provided information, the Consensus hip systems are implantable surgical devices, not IVDs.

N/A

Intended Use / Indications for Use

The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications.

The indications for use are:

  • A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
  • B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
  • C. Proximal femoral fractures.
  • D. Avascular necrosis of the femoral head.
  • E. Non-union of proximal femoral neck fractures.
  • F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

Product codes

LPH, LZO

Device Description

The Consensus hip systems are semi-constrained, hip prosthesis designed for either The Consensuring bio surgery. They include the Consensus® Hip System (CHS), the Unisyn™ Hip System, and the TaperSet™ Hip System (THS). All three hip systems utilize the exact same 12/14 Morse taper trunnion. These hip stems are compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.

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)

No clinical studies were performed.

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

Not Found

Predicate Device(s)

K935193, K935453, K933499, K922561, K070061, K953792, K955386, K960339, K960156, K960151, K060635, K021466, K020153, K953198, K100933, K03015

Reference Device(s)

K081973, K082991

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

Page 1 of 3

2. 510(k) SUMMARY

APR - 1 2011

| Sponsor Name: | Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills, CA 95762 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Matthew M. Hull, RAC
Phone: (916) 355-7156/ Fax: (916) 355-7190
mhull@consensusortho.com |
| Date Prepared: | 24 February, 2011 |
| Trade Name: | Consensus® Hip System, Unisyn Hip System, TaperSet™ Hip
System |
| Common Name: | Porous-coated hip prostheses for uncemented use
Non-porous coated hip prostheses for uncemented or cemented
use |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated
uncemented prosthesis is a Class II device per 21 CFR
888.3358 (Product Code LPH).
Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis is a Class II device per 21
CFR 888.3353 (Product Code LZO). |

11 0542

Device Description:

The Consensus hip systems are semi-constrained, hip prosthesis designed for either The Consensuring bio surgery. They include the Consensus® Hip System (CHS), the Unisyn™ Hip System, and the TaperSet™ Hip System (THS). All three hip systems utilize the exact same 12/14 Morse taper trunnion. These hip stems are compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.

Indications for Use:

The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications.

The indications for use are:

  • A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
  • B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
  • C. Proximal femoral fractures.

1

  • D. Avascular necrosis of the femoral head.
  • E. Non-union of proximal femoral neck fractures.
  • F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

Substantial Equivalence:

Technological Characteristics/Substantial Equivalence:

The Consensus hip systems are similar to the predicate Aesculap system in basic design and indications. The predicate Aesculap stems and heads were cleared for use with the Consensus CS2 Acetabular Cup System under K081973. Zirconia ceramic femoral heads were previously cleared with CHS, Unisyn, and THS under various 510(k) submissions. The subject Biolox delta ceramic femoral heads were cleared for use with the predicate Aesculap hip systems under K082991. Based on the material, characterization data, geometry and mechanical testing, use of the Biolox delta femoral head with the Consensus hip systems is substantially equivalent to legally marketed predicates.

Legally Marketed Devices to which Substantial Equivalence is claimed:

K935193 (U.S. Medical Products) Consensus' Hip System - Porous Coated Titanium Femoral Stem

K935453 (U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM FEMORAL STEM

11 ANDIN I LIMORAL DYLM
K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANIUM FEMORAL STEM K922561 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM

K070061 (Hayes Medical, Inc.) Consensus Hip System 36 mm CoCr Femoral Head K953792 (U.S. Medical Products) CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 K955386 (U.S. Medical Products) CONSENSUS ZIRCONIA FEMORAL HEAD K960339 (U.S. Medical Products) CONSENSUS 22MM COCRMO FEMORAL HEAD K960156 (U.S. Medical Products) CONSENSUS 32MM COCRMO FEMORAL HEAD K960151(U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD K060635 (Hayes Medical, Inc.) Consensus Total Hip System, Acetabular Cup K021466 (Hayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K 020153 (Hayes Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW K100933 (Consensus) Consensus Acetabular insert, CS2 Plus K03015 | (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM

K102399 (Consensus) TaperSet Hip System

K 081973 (Aesculap) Consensus Acetabular Cups for use with Aescualp Excia and Metha Hip Systems

K082991 (Aesculap) Biolox Delta Ceramic Femoral Head

2

Non-Clinical Performance Data:

  • All required testing per "Guidance Document for the Preparation of Premarket . Notifications of Ceramic Ball Hip Systems" were performed.
    2110542

  • Component testing of BIOLOX forte ball head 28-12/14 L on titanium test tapers . per CeramTec AG test procedure VA 02 04 4129, ISO 7206-10.

  • Influence of diameter and neck length on burst strength of BIOLOX forte and . BIOLOX delta ball heads with taper type 12/14. Burst test setup as per ISO 7206-10.

Clinical Performance Data:

No clinical studies were performed..

3

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wings. The eagle faces right and has a small, round head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Consensus Orthopedics, Inc. % Matthew Hull, RAC 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762-9623

APR - 1 2011

Re: K110542

Trade/Device Name: Consensus Biolox Delta Ceramic Femoral Heads 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, LZO Dated: February 22, 2011 Received: February 24, 2011

Dear Mr. Hull:

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

4

Page 2 - Matthew Hull, RAC

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 practive 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson

OS/CLINO

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

5

1. INDICATIONS FOR USE STATEMENT

110542 510(k) Number (if known):

Device Name: BIOLOX® delta Ceramic Femoral Heads (w/ Consensus hip systems)

Indications for Use:

The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications.

The general indications for use are:

  • A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
  • B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
  • C. Proximal femoral fractures.
  • D. Avascular necrosis of the femoral head.
  • E. Non-union of proximal femoral neck fractures.
  • F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

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

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melkerom

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110542