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.
Device Story
Consensus Hip System (CHS), Unisyn Hip System, and TaperSet Hip System (THS) are semi-constrained hip prostheses for total or partial hip arthroplasty. Systems utilize a standardized 12/14 Morse taper trunnion for modular assembly with femoral heads (including Biolox delta ceramic), acetabular cups, and inserts. Used by orthopedic surgeons in clinical settings for patients with degenerative or traumatic hip joint failure. Implants are fixed via cemented or uncemented techniques. Device provides structural replacement of the femoral head to restore joint function and mobility; benefits include improved joint stability and pain relief.
Clinical Evidence
No clinical studies were performed. Evidence is based on bench testing, including component testing of BIOLOX forte ball heads on titanium tapers per CeramTec AG procedure VA 02 04 4129 and ISO 7206-10, and burst strength testing of BIOLOX forte and delta heads per ISO 7206-10.
Technological Characteristics
Semi-constrained hip prosthesis; modular 12/14 Morse taper trunnion interface. Materials include titanium alloy stems and Biolox delta ceramic femoral heads. Designed for cemented or uncemented fixation. Compatible with CoCr, zirconia, and ceramic heads, and UHMWPE inserts. Testing performed per ISO 7206-10 and FDA guidance for ceramic ball hip systems.
Indications for Use
Indicated for patients requiring total or partial hip arthroplasty due to rheumatoid, osteoarthritis, post-traumatic arthritis, failed previous hip procedures, proximal femoral fractures, avascular necrosis, non-union of femoral neck fractures, congenital dysplasia, or other metabolic/structural hip conditions.
Regulatory Classification
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.
K201657 — Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads · Corin, Ltd. · Jul 28, 2021
K140547 — EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM · Excera Orthopedics, Inc. · Jan 22, 2015
K163585 — Responsive Orthopedics Total Hip Arthroplasty System · Responsive Orthopedics, LLC · Jun 2, 2017
K133370 — REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE · Signature Orthopaedics Pty Limited · Jul 22, 2014
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Page 1 of 3
### 2. 510(k) SUMMARY
APR - 1 2011
| Sponsor Name: | Consensus Orthopedics, Inc.<br>1115 Windfield Way, Suite 100<br>El Dorado Hills, CA 95762 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Matthew M. Hull, RAC<br>Phone: (916) 355-7156/ Fax: (916) 355-7190<br>mhull@consensusortho.com |
| Date Prepared: | 24 February, 2011 |
| Trade Name: | Consensus® Hip System, Unisyn Hip System, TaperSet™ Hip<br>System |
| Common Name: | Porous-coated hip prostheses for uncemented use<br>Non-porous coated hip prostheses for uncemented or cemented<br>use |
| Classification Name: | Hip joint metal/polymer/metal semi-constrained porous-coated<br>uncemented prosthesis is a Class II device per 21 CFR<br>888.3358 (Product Code LPH).<br>Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis is a Class II device per 21<br>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.
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- 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
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# 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.
彩
# Clinical Performance Data:
No clinical studies were performed..
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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
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## 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
Panel 1
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