(70 days)
No
The document describes a mechanical hip implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are based on mechanical testing.
Yes.
The device is a hip implant designed to treat conditions like arthritis, fractures, and avascular necrosis, which are therapeutic interventions.
No
Explanation: This device is a TaperSet Hip System, which is an orthopedic implant designed for total or partial hip arthroplasty. Its purpose is to replace or address issues in the hip joint, not to diagnose medical conditions.
No
The device description clearly states it is a monolithic, titanium alloy tapered hip stem, which is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The TaperSet™ Hip System is a surgical implant designed for total or partial hip replacement. It is a physical device implanted into the body to restore function to a damaged hip joint.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or the detection of diseases or conditions through in vitro methods.
The device is clearly a surgical implant used in orthopedic procedures.
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 TaperSet™ hip stem is indicated for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWL, KWY
Device Description
The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CP Ti coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes currently 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 or Biolox delta ceramic heads, unipolar heads, bipolar heads. UHMWPE inserts and acetabular cups. The modification addressed here is the addition of two stems in sizes 5mm and 6mm.
The new stems are manufactured from forged titanium alloy (Ti-6AI-4V ELI, ASTM F620) and the proximal portion of the femoral stem component is plasma sprayed with commercially pure titanium (C. P. Ti. ASTM F1580). The new femoral stems are available in both standard and 7mm lateralized options and have the identical neck and taper design, and porous coating as the predicate TaperSet stems cleared under K102399 in design and indications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral head, femoral neck
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)
The TaperSet small stems are identical to the predicate TaperSet stems cleared under K102399 in design, materials, packaging, and indications, the two new stems (5 & 6 mm) are just smaller in overall dimensions and thus created a new worst-case configuration. The 5mm lateral femoral stem was determined to be the worst-case example per analysis report (R11-007). The stems were to achieve 5 million cycles of loading at a maximum load of 517 lbs. (2300 N) without failure in accordance with ASTM F2068-2009 and ISO 7206-4:2010(E).
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.
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.
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.
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K12/935
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2. 510(k) SUMMARY
| Page 1 of 3 | |
|---|---|
| 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: | 14 August, 2012 |
| Trade Name: | TaperSetTid Hip System Small Stems |
| Common Name: | Porous-coated hip prosthesis for cementless use |
| Classification Name: | Class II device |
| Hip ioint metal/polymer/metal semi-constrained porous-coated | |
| uncemented prosthesis: 21 CFR 888.3358, Product Code LPH. | |
| Hip ioint metal/ceramic/polymer semi-constrained cemented or | |
| nonporous uncemented prosthesis: 21 CFR 888.3353, Product | |
| Code LZO. | |
| Hip joint femoral (hemi-hip) metallic cemented or uncemented | |
| prosthesis: 21 CFR 888.3360, Product Code KWL. | |
| Hip joint femoral (hemi-hip) metal/polymer cemented or | |
| uncemented prosthesis: 21 CFR 888.3390. Product Code KWY. |
Device Description:
The TaperSet Hip System (THS) is a monolithic, titanium alloy tapered hip stem design with a proximal, plasma sprayed, porous CP Ti coating. The stem has a dual wedge geometry and is available in both standard and 7mm lateral offsets in sizes currently 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 or Biolox delta ceramic heads, unipolar heads, bipolar heads. UHMWPE inserts and acetabular cups. The modification addressed here is the addition of two stems in sizes 5mm and 6mm.
Stem
The new stems are manufactured from forged titanium alloy (Ti-6AI-4V ELI, ASTM F620) and the proximal portion of the femoral stem component is plasma sprayed with commercially pure titanium (C. P. Ti. ASTM F1580). The new femoral stems are available in both standard and 7mm lateralized options and have the identical neck and taper design, and porous coating as the predicate TaperSet stems cleared under K102399 in design and indications.
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K12/935
Page 2 of 3
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 TaperSet™ hip stem is indicated for cementless use.
Substantial Equivalence:
Technological Characteristics/Substantial Equivalence:
The new smaller stems for the TaperSet Hip System have the same design, porous coating. and indications as the predicate TaperSet stems cleared under K102399. Taper style femoral stems in sizes 5 and 6 mm were previously cleared by FDA under K103755 for the Biomet Taperloc Complete Hip System extension. The subject Consensus stems are still compatible with previously cleared CoCr heads, zirconia and Biolox delta ceramic heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups. Based on the material, characterization data, and geometry, the TaperSet Hip small stems are substantially equivalent to the legally marketed predicates.
Non-Clinical Performance Data:
The TaperSet small stems are identical to the predicate TaperSet stems cleared under K102399 in design, materials, packaging, and indications, the two new stems (5 & 6 mm) are just smaller in overall dimensions and thus created a new worst-case configuration. The 5mm lateral femoral stem was determined to be the worst-case example per analysis report (R11-007). The stems were to achieve 5 million cycles of loading at a maximum load of 517 lbs. (2300 N) without failure in accordance with ASTM F2068-2009 and ISO 7206-4:2010(E).
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12/935 Page 3/3
Page 3 of 3
Based upon engineering analysis and testing of the design modification the new 5 & 6 mm femoral stems for the TaperSet Hip System by Consensus are substantially equivalent to devices currently marketed. Therefore, the device is as safe, as effective, and performs at least as safely and effectively as the 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 stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Consensus Orthopedics, Incorporated % Mr. Matthew M. Hull, RAC Director, QS & RA 1115 Windfield Way, Suite 100 El Dorado Hills, California 95762 .
SEP
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2012
Re: K121935
Trade/Device Name: TaperSet™ Hip System Small Stems Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coat-ed uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWL, KWL, KWY Dated: August 14, 2012 Received: August 15, 2012
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 - Mr. Matthew M. 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 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 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.
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 (if known): TBD K | 2 | 935
Device Name: TaperSet™ Hip System Small Stems
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.
- A. Significantly impaired ioints 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.
- Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa F. plana, 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.
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)
Elizabeth R.
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
K121935 510(k) Number .