(29 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The focus is on mechanical testing and equivalence to a predicate device.
Yes
The device is a hip stem used for various conditions including arthritis, avascular necrosis, and fractures, all of which are medical conditions that benefit from treatment.
No
The device is a hip stem implant used for uncemented biological fixation, addressing conditions like degenerative joint disease and fractures. Its purpose is treatment and correction, rather than diagnosing medical conditions.
No
The device description and performance studies clearly indicate this is a physical hip stem implant, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for uncemented biological fixation of hip stems, which are implanted devices used in hip replacement surgery. This is a surgical procedure, not a diagnostic test performed on samples outside the body.
- Indications for Use: The indications are for various conditions affecting the hip joint, requiring surgical intervention.
- Device Description: The device is described as a line extension of hip stems, which are physical implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information. The device is a therapeutic implant.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Taperloc Complete hip stems are intended for uncemented biological fixation. This is the same intended use as the predicate Taperloc® stems cleared in K101086.
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.
Product codes (comma separated list FDA assigned to the subject device)
KWA, LZO, KWZ, JDL, JDI, MAY, MEH, LPH, KWL, LWJ, KWY
Device Description
The Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems cleared in K101086.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, femoral
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:
Non-clinical fatigue testing was conducted to demonstrate that the modifications proposed in this submission raise no new issues of safety and effectiveness of the modified components as compared to the predicate hip stems.
Distal Pot Fatigue testing was conducted in accordance with ASTM F-1612-95, Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion. All components passed distal pot cyclic fatigue testing.
Proximal Pot Fatigue testing was conducted in accordance with ASTM F-2068-03 Standard Specification for Femoral Prostheses - Metallic Implants. All components passed distal pot cyclic fatigue testing.
Clinical Testing:
Clinical testing is not necessary to demonstrate substantial equivalence to the predicate components.
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.
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
§ 888.3330 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.
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1/21/11
K103755
JUNET . * MANUFACTURING CORP.
510(k) Summary
| Preparation Date: | December 22, 2010 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| 56 East Bell Drive | |
| P.O. Box 587 | |
| Warsaw, Indiana 46581-0587 | |
| FDA Registration Number: 1825034 | |
| Contact Person: | Becky Earl |
| Regulatory Specialist | |
| Biomet Manufacturing Corp. | |
| Phone: (574) 267-6639 | |
| Fax: (574) 372-1683 | |
| becky.earl@biomet.com | |
| Proprietary Name: | Taperloc® Complete, Sizes 5mm and 6mm |
| Common Name: | Uncemented porous modular hip prosthesis. |
| Classification Code(s)/Name(s): | LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous |
| uncemented prosthesis (21 CFR §888.3353) | |
| KWA - Hip joint metal/metal semi-constrained, with an uncemented acetabular | |
| component, prosthesis (21 CFR §888.3330) | |
| KWZ - Hip joint metal/polymer constrained cemented or uncemented prosthesis | |
| (21 CFR§888.3310) | |
| JDL - Hip joint metal/metal semi-constrained, with a cemented acetabular | |
| component, prosthesis (21 CFR §888.3320) | |
| JDI - Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR | |
| §888.3350) | |
| MAY - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous | |
| uncemented prosthesis (21 CFR §888.3353) | |
| MEH - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous | |
| uncemented prosthesis (21 CFR §888.3353) | |
| LPH- Hip joint metal/polymer/metal semi-constrained porous-coated uncemented | |
| prosthesis (21 CFR §888.3358) |
Malling Address:
P.O. Box 587 1107 - 10:153w, IN 46581-0587
Toll Free: 800,348.9500 Office: 574.267.6639 Main Fax: 574.287.8137
www.biomel.com Shipping Address: 56 E. Bell Drive
Warsaw, IN 46582
1
KWL - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR§888.3360) LWJ - Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21 CFR 888.3360) KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR §888.3390)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Taperloc® Complete, K101086
Device Description:
The Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems cleared in K101086.
Intended Use:
The Taperloc Complete hip stems are intended for uncemented biological fixation. This is the same intended use as the predicate Taperloc® stems cleared in K101086.
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.
Summary of Technologies:
The Taperloc® Complete, Size 5mm and 6mm hip stems are a line extension to the predicate Taperloc hip stems cleared in K101086. The subject stems are manufactured from the same materials, conforming to the same standards, as the predicate Taperloo stems. The Indications for Use have remained the same.
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Non-Clinical Testing:
Non-clinical fatigue testing was conducted to demonstrate that the modifications proposed in this submission raise no new issues of safety and effectiveness of the modified components as compared to the predicate hip stems.
Distal Pot Fatigue testing was conducted in accordance with ASTM F-1612-95, Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion. All components passed distal pot cyclic fatigue testing.
Proximal Pot Fatigue testing was conducted in accordance with ASTM F-2068-03 Standard Specification for Femoral Prostheses - Metallic Implants. All components passed distal pot cyclic fatigue testing.
Clinical Testing:
Clinical testing is not necessary to demonstrate substantial equivalence to the predicate components.
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-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
JAN 2 1 201
Re: K103755
Trade/Device Name: Taperloc® Complete, Sizes 5mm and 6mm 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, LZO, KWZ, JDL, JDI, MAY, MEH, LPH, KWL, LWJ, KWY Dated: December 22, 2010 Received: December 23, 2010
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, 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
. .
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Page 2 - Ms. Becky Earl
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" (2) CFR 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.
F. R. Petham
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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K103755
Page I of I
3
Indications for Use
510(k) Number (if known):_
Taperloc® Complete, Sizes Smm and 6mm Device Name: __
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 4. 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)
for M. Melbern
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
51.0(k) Number K103755