(231 days)
No
The summary describes a mechanical hip implant and its performance testing, with no mention of AI or ML.
Yes
The device is designed to replace natural hip, femoral neck, and head due to disease or accident, and is indicated for conditions like osteoarthritis, rheumatoid arthritis, correction of functional deformity, and treatment of fractures, which are therapeutic interventions.
No
Explanation: The device description states it is designed to "replace the patient's natural hip, femoral neck, and head, due to disease or accident," which indicates it is a therapeutic device (an implant) rather than a diagnostic one. The "Intended Use / Indications for Use" section also lists conditions for which the device is used as a treatment option, not for their detection or diagnosis.
No
The device description clearly describes a physical implant (femoral stems) made of Ti-6AI-AV with porous plasma spray, intended to replace parts of the hip. This is a hardware device, not software.
Based on the provided information, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the TaperIoc® Complete Microplasty Stems are designed to replace the patient's natural hip, femoral neck, and head. This is an implantable medical device used in surgery.
- Intended Use: The intended uses listed are all related to treating musculoskeletal conditions through surgical intervention and implantation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Porous coated components are intended for uncemented biological fixation.
Indications for Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis
- Correction of functional deformity 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4. head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed. 5.
Product codes
KWA, LPH, JDL, LZO, KWZ, JDI, KWY, MEH, KWL, QOG
Device Description
The TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, femoral neck, and head
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
Nonclinical performance testing included distal and proximal stem fatigue testing of the worst-case stem, consistent with the "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses", ISO 7206-4:2002, ASTM F2068-03 and ISO 7206-6:1992, as well as a Range of Motion analysis consistent with ISO 21535:2009. All 6 stems passed distal stem fatigue for 5 million cycles at 67 lbs to 517lbs, meeting the acceptance criteria. All 6 stems passed 10 million cycles at 120lbs in proximal fatigue test, meeting the acceptance criteria. The minimum Range of Motion passed its simulation, meeting the acceptance criteria.
Additional Ti-alloy (ASTM F1580) plasma sprayed metallic coating characterization data was performed for clarification per the "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" and per the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The PPS plasma sprayed coating is the same as the PPS coating previously cleared and meets the regulatory definition of porous coating for the hip construct per 21 CFR 888.3358.
Clinical Testing: None provided as a basis for substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Taperloc® Complete Stems-Biomet-(K101086), Lateralized Taperioc® Microplasty Femoral Components -Biomet-(K062994), Taperloc® Complete, Sizes 5mm and 6mm-Biomet-(K103755), Fitmore® Hip Stem-Zimmer-(K071723)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
t : 1 4 2 2 - - 1 8 -MANUFACTURING CORP.
| 510(k) Summary
| SEP 30 2011 | |
|---|---|
| Preparation Date: | September 29, 2011 |
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| 56 East Bell Drive | |
| P.O. Box 587 | |
| Warsaw, IN 46581-0587 | |
| Establishment Registration Number: 1825034 | |
| Contact Person: | Becky Earl |
| Regulatory Specialist | |
| Proprietary Name: | Taperloc® Complete Microplasty System |
| Common Name: | Uncemented porous modular hip prosthesis |
| Classification Name: | Hip joint metal/metal semi-constrained, with an uncemented acetabular |
| component, prosthesis (21 CFR §888.3330) | |
| LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous | |
| Uncemented (21 CFR 888.3358) | |
| KWA-Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular | |
| Component) (21 CFR 888.3330) | |
| JDL- Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular | |
| Component) (21 CFR 888.3320) | |
| LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, | |
| Cemented or Non-Porous, Uncemented (21 CFR 888.3353) | |
| KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, | |
| Metal/Polymer (21 CFR 888.3310) | |
| JDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 | |
| CFR 888.3350) | |
| KWY-Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or | |
| Uncemented (21 CFR 888.3390) | |
| MEH-Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, | |
| Non-Porous, Calcium-Phosphate (21 CFR 888.3353) | |
| KWL-Hip Joint Femoral (Hemi-Hip) Metallic Cemented or Uncemented | |
| Prosthesis (21 CFR 888.3360) | |
| OQG-Prosthesis, hip, semi-constrained, metal/polymer + additive, porous | |
| uncemented (888.3358) |
Malling Address: P.O. Box 587 Warsaw, IN. 46581-0587 800.348.9500 Toll Free: Office: 574.267.6639 574-267-8137 Main Fax: www.biomet.com
Shipping Address: 56 E Bell Drive Warsaw, IN 46582
1
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Taperloc® Complete Stems-Biomet-(K101086)
Lateralized Taperioc® Microplasty Femoral Components -Biomet-(K062994)
Taperloc® Complete, Sizes 5mm and 6mm-Biomet-(K103755)
Fitmore® Hip Stem-Zimmer-(K071723)
Device Description:
The TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.
Intended Use:
Porous coated components are intended for uncemented biological fixation.
Indications for Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis
- Correction of functional deformity 3.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4. head involvement, unmanageable by other techniques.
- Revision procedures where other treatment or devices have failed. 5.
Porous coated components are intended for uncemented biological fixation.
Summary of Technologies:
The technological characteristics are the same as the predicates identified in the Legally Marketed Devices to which substantial equivalence is claimed. The subject microplasty stems are designed to update the existing Taperloc® Microplasty implants (K062994) to join the Taperloc® Complete family of stems as a microplasty option. The subject microplasty stems combine the design features of the Taperloc® Complete full-length stems (K101086 and K103755) and the shortened design of the Taperloc® Microplasty stems, both standard and high offset, or lateralized (K062994). Technological characteristics include a tapered wedge, a porous plasma sprayed region, a modified shortened trunnion (Type 1), a reduced neck angle, two distal profiles and an updated insertion/extraction hole, identical to the Taperloc® Complete full-length stem predicates (K101086 and K103755). Stem lengths are within the range of the legally marketed predicates.
Non-Clinical Testing:
Nonclinical performance testing included distal and proximal stem fatigue testing of the worst-case stem, consistent with the "Guidance for Industry and FDA Staff Non-clinical Information for Femoral Stem Prostheses", ISO 7206-4:2002, ASTM F2068-03 and ISO 7206-6:1992, as well as a Range of Motion analysis consistent with ISO 21535:2009. All 6 stems passed distal stem fatigue for 5 million cycles at 67 lbs to 517lbs,
2
meeting the acceptance criteria. All 6 stems passed 10 million cycles at 120lbs in proximal fatigue test, meeting the acceptance criteria. The minimum Range of Motion passed its simulation, meeting the acceptance criteria.
Additional Ti-alloy (ASTM F1580) plasma sprayed metallic coating characterization data was performed for clarification per the "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" and per the "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements." The PPS plasma sprayed coating is the same as the PPS coating previously cleared and meets the regulatory definition of porous coating for the hip construct per 21 CFR 888.3358.
Clinical Testing:
None provided as a basis for substantial equivalence.
The results of mechanical testing indicated the devices performed within the intended use, did not raise any new safety and efficacy issues and were found to be substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo features a stylized depiction of three birds in flight, arranged vertically. The birds are simple, with curved lines suggesting their wings and bodies. Encircling the birds is text that follows the curve of the circle. The text is small and somewhat difficult to read, but it appears to be the name of an organization or agency.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W056-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, IN 46581
cca 3 0 2711
Re: K110400
Trade/Device Name: Taperloc® Complete Microplasty System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LPH, JDL, LZO, KWZ, JDI. KWY, MEH, KWL, QOG Dated: September 20, 2011 Received: September 21. 2011
Dear Ms. Earl:
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. Ilisting 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 -- Ms. Becky Earl
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 (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
ff 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/ReportalProblem/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,
Erin S. Keith
Cr Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): _ K | 104000000001/1 )
Device Name: Taperloc® Complete Microplasty
Indications For Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis
-
- 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.
Porous coated components are intended for uncemented biological fixation.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
ihankhens for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110400