(100 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and compatibility of the hip implant components, with no mention of AI or ML.
Yes
The device is a hip implant, designed to treat impaired joints and other conditions of the hip, thus providing a therapeutic benefit by restoring function.
No
Explanation: The device is a total hip replacement system, indicated for conditions like impaired joints and fractures, and is used in hip arthroplasty. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a monolithic, titanium alloy hip stem, which is a physical hardware 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 is for total or partial hip arthroplasty, addressing various conditions affecting the hip joint. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a hip stem, a physical implant designed to be surgically placed within the femur.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the TaperSet Hip System does not involve any such testing or analysis of biological samples.
The TaperSet Hip System is a surgical implant used in orthopedic procedures, not a diagnostic device.
N/A
Intended Use / Indications for Use
The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.
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
The TaverSet™ hip stem is indicated for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWL, KWL, KWY
Device Description
The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is 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)
Non-clinical testing and analysis were provided, including bench testing and coating Noll-cinical testing and matiyals were projectal fatigue testing and proximal fatigue testing of the worst case stem consistent with the "Guidance for Industry and FDA Staff Non-clinical worst case stein consistent with are " Sus." Range of motion analysis was also performed. The Information 101 Femoral of in Probacter and event characterization per FDA's "Guidance CPT piasma sprayed than in coating ander Modified Metallic Surfaces Apposing Bone of Document For Testing Orthopodio Infplants "Marialic Plasma Sprayed Coatings on Bone Cement and "Guldance for made Postmarket Surveillance Requirements?" The Orthopedit implains to Support reconsisterization of porosity per 21 CFR 888.3358. Modular connection analyses including fretting and corrosion of metallic femoral heads in addition to ceramic head compatibility were also performed.
All of the observed results indicate that the TaperSet Hip System is substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.
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.
K043537, K921301, K030151, K030191, K935453, K933499, 1033 723, K922560, K070061, K953792, K955386, K960339, 1960156, 15960150, R 0013, K030205, R050205, K020153, K953198, K100933
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
§ 888.3358 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
| Sponsor Name: | Consensus Orthopedics, Inc.
1115 Windfield Way, Suite 100
El Dorado Hills, CA 95762 | | | DEC 2 2010 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|------------|
| 510(k) Contact: | Matthew M. Hull, RAC
Phone: (916) 355-7156/ Fax: (916) 355-7190
mhull@consensusortho.com | | | |
| Date Prepared: | 29 November, 2010 | | | |
| Trade Name: | TaperSet™ Hip System | | | |
| Common Name: | Porous-coated hip prosthesis for cementless 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). | | | |
Device Description:
The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CPTi coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes designated as 7.5mm to 24mm. The stems feature a neck shaft angle of 135° and a 12/14 Morse taper trunnion. The TaperSet Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System. The stem is compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.
Indications for Use:
The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.
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.
- Non and or promised as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, F. Coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.
The TaperSet™ hip stem is indicated for cementless use.
1
Substantial Equivalence:
Technological Characteristics/Substantial Equivalence:
The TaperSet Hip System is similar to the predicate systems in basic design and indications. The monolithic stem with porous CPTi coating is considered to have the same type of technological monomics over with provet K043537 stem with differences in the stem geometry and exterior coating. The subject stem is compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bigolar heads, UHMWPE inserts and acetabular cups. Based on the material, characterization data, geometry and mechanical testing, the TaperSet Hip is substantially equivalent to legally marketed predicates.
Legally Marketed Devices to which Substantial Equivalence is claimed:
K043537 (Biomet) Taperloc® 12/14 Taper Femoral components K921301 (Biomet) TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM K030151 (Hayes Medical, Inc.) CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM K030191 (Tiayes Medical Products) Consensus' Hip System - Porous Coated Titanium Pemoral Stem K935453 (U.S. Medical Products) CONSENSUS(TM) HIP SYSTEM-HA COATED TITANIUM
FEMORAL STEM I EMORAL STEM
K933499 (U.S. Medical Products) CONSENSUS HIP SYSTEM- NON-POROUS TITANUM 1033 723 (U.S. Medical Products) CONSENSUS(TM) TOTAL HIP SYSTEM K922560 (U.S. Medical Products) CONSENSUS(TM) BIPOLAR 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 1960156 (U.S. Medical Products) CONSENSUS 32MM COCRMO FEMORAL HEAD 15960150 (U.S. Medical Products) CONSENSUS 26MM COCRMO FEMORAL HEAD R 0013 ( Q: 0: 11 Nical Consensus Total Hip System, Acetabular Cup K030205 (Hayes Medical, Inc.) CONSENSUS UNIPOLAR HEAD, COCR R050205 (Tayes Medical, Inc.) CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENE K020153 (Hayes Medical, Inc.) CONSENSUS ACETABLAR SHELL, TI COATED K953198 (Hayes Medical, Inc.) CORTICELLOUS BONE SCREW K100933 (Consensus) Consensus Acetabular insert, CS2 Plus
Non-Clinical Performance Data:
Non-clinical testing and analysis were provided, including bench testing and coating Noll-cinical testing and matiyals were projectal fatigue testing and proximal fatigue testing of the worst case stem consistent with the "Guidance for Industry and FDA Staff Non-clinical worst case stein consistent with are " Sus." Range of motion analysis was also performed. The Information 101 Femoral of in Probacter and event characterization per FDA's "Guidance CPT piasma sprayed than in coating ander Modified Metallic Surfaces Apposing Bone of Document For Testing Orthopodio Infplants "Marialic Plasma Sprayed Coatings on Bone Cement and "Guldance for made Postmarket Surveillance Requirements?" The Orthopedit implains to Support reconsisterization of porosity per 21 CFR
2
888.3358. Modular connection analyses including fretting and corrosion of metallic femoral heads in addition to ceramic head compatibility were also performed.
All of the observed results indicate that the TaperSet Hip System is substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as legally marketed predicates.
3
Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines and a stylized base.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Consensus Orthopedics. Inc. % Matthew M. Hull, RAC Director QS & RA 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762
DEC 2 2010
Re: K102399 Trade/Device Name: TaperSet™ Hip System 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, KWL, KWL, KWY Dated: November 10, 2010 Received: November 10, 2010
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 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
4
Page 2 - Mr. Matthew M. Hull, RAC
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.
lf 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For Rob Dumin Dir
Mark N. Melkerson
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
510(k) Number: K102399
Device Name: TaperSet™ Hip System
Indications for Use:
The TaperSet™ Hip System is designed for total or partial hip arthroplasty and is intended to be used with compatible components of the Consensus Hip System.
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
The TaverSet™ hip stem is indicated for cementless use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Sonita for mkm
(Division Sign-off)
Division of Surgical. O thonedic. and Restorative Devices
510(k) Number K102399