(316 days)
Not Found
No
The summary describes a mechanical implant device (hip stem) and its material properties and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for hip joint arthroplasty to treat various conditions like degenerative joint disease, rheumatoid arthritis, and fractures, which are therapeutic interventions.
No
The device is described as an implantable hip stem for arthroplasty, which is a therapeutic treatment rather than a tool for diagnosis.
No
The device description clearly states it is an "implant device, a porous coated femoral stem intended for uncemented biological fixation," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Taperloc® Complete Hip Stems are for "hip joint arthroplasty" and lists various conditions related to the hip joint and proximal femur. This is a surgical implant used in the body.
- Device Description: The description confirms it is an "implant device, a porous coated femoral stem intended for uncemented biological fixation." This is a physical device implanted during surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body.
The information provided describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / 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.
- Revision procedures where other treatment or devices have failed.
Product codes
LZO, KWZ, JDI, MAY, MEH, LPH, KWL, KWY
Device Description
Taperloc® Complete Hip Stems are an implant device, a porous coated femoral stem intended for uncemented biological fixation. The Taperloc® Complete is a series of hip stems with a bi-planar wedge design, titanium substrate, and proximally circumferential titanium porous plasma sprayed design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Non-Clinical Tests:
- Porous Plasma Spray Coating testing was performed on samples of robotically applied coating versus predicate manually applied coating. Testing included: Tensile (ASTM 1147), Fatigue (ASTM (F1160), Porosity (ASTM F1854), Pore Size (ASTM F1854), Thickness (ASTM F1854), Tabor Abrasion (ASTM F1978), Shear Fatigue (ASTM F1160), Shear Static ASTM (F1044), Roughness (comparison to predicate). All testing passed and met the specifications or comparison testing (as applicable) to the predicate devices.
- One-Step Forging Distal Pot Up/Down Fatigue testing was performed on samples of single forged hip stem material and compared to predicate double forged hip stem material. Testing included: Rotating Beam Fatigue (ASTM STP 731). All testing passed and met specifications and comparison to the predicate device.
Clinical Tests: None provided.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue and white.
December 8, 2020
Biomet Orthopedics Genoa Atwood Regulatory Affairs, Sr. Specialist 56 East Bell Drive, PO Box 587 Warsaw, Indiana 46581
Re: K200196
Trade/Device Name: Taperloc® Complete Hip Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, KWZ, JDI, MAY, MEH, LPH, KWL, KWY Dated: November 12, 2020 Received: November 13, 2020
Dear Genoa Atwood:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number
Device Name
Taperloc® Complete Hip Stems
Indications for Use (Describe)
-
- 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Taperloc® Complete Hip Stems 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.
| Sponsor: | Biomet Orthopedic
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 | Primary Predicate | 510(k) Number |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|---------------|
| Primary Contact
Person: | Genoa Atwood
Regulatory Affairs Sr. Specialist
Telephone: (864) 553-9153 | Taperloc® Complete Hip Stems | K101086 |
| Secondary Contact
Person: | Rhonda Myers
Regulatory Affairs Sr. Project Manager
Telephone: (574) 373-9659 | | |
| Date: | January 2, 2020 | | |
| Subject Device: | Trade Name: Taperloc® Complete Hip Stems
Common Name: Uncemented porous modular hip prosthesis | | |
| Classification Name: | • LZO - Hip joint metal/ceramic/polymer semi constrained
cemented or nonporous uncemented prosthesis (21
CFR 888.3353)
• KWZ- Hip joint metal/polymer constrained cemented
uncemented prosthesis (21 CFR 888.3310)
• 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)
• KWL- 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) | | |
4
Predicate Device:
| Purpose and Device
| Description: | Taperloc® Complete Hip Stems are used for hip arthroplasty. |
|---|---|
| Taperloc® Complete Hip Stems are an implant device, a porous | |
| coated femoral stem intended for uncemented biological fixation. | |
| The Taperloc® Complete is a series of hip stems with a bi-planar | |
| wedge design, titanium substrate, and proximally circumferential | |
| titanium porous plasma sprayed design. | |
| The purpose of this submission is: | |
| • To submit a 510(k) for cumulative changes made to the system | |
| since original clearance; | |
| ○ The distal profile of the Taperloc Complete 9mm Reduced | |
| Distal Profile hip stems was reduced in diameter, | |
| ○ The Porous Plasma Spray Process was changed to an | |
| automatic process, | |
| ○ The manufacturing process was changed from a double | |
| forging process step to a single-forging step. | |
| Intended Use and | The Taperloc® Complete Hip Stems are intended for hip joint |
| arthroplasty. | |
| Indications for Use: | 1. 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
Technological
Characteristics: | The rationale for substantial equivalence is based on consideration of
the following characteristics:
• Intended Use: Identical to predicate
• Indications for Use: Identical to predicate
• Materials: Identical to predicate
• Design Features: Similar to predicate |
| | • Sterilization: Similar to predicate |
5
Summary of Performance Data: (Nonclinical and/or Clinical)
Non-Clinical Tests:
- Porous Plasma Spray Coating testing was performed on samples of ● robotically applied coating versus predicate manually applied coating. Testing included:
- Tensile (ASTM 1147) O
- Fatigue (ASTM (F1160) O
- Porosity (ASTM F1854) O
- Pore Size (ASTM F1854) O
- Thickness (ASTM F1854) o
- Tabor Abrasion (ASTM F1978) O
- Shear Fatigue (ASTM F1160) O
- Shear Static ASTM (F1044) O
- Roughness (comparison to predicate) O
All testing passed and met the specifications or comparison testing (as applicable) to the predicate devices.
- One-Step Forging Distal Pot Up/Down Fatigue testing was performed on samples of single forged hip stem material and compared to predicate double forged hip stem material. Testing included:
- Rotating Beam Fatigue (ASTM STP 731) O
All testing passed and met specifications and comparison to the predicate device.
Clinical Tests:
-
None provided ●
The proposed Taperloc® Complete Hip Stems have the same intended use and indications for use as the predicate devices. The proposed devices have similar technological characteristics to the predicates, and the information provided herein demonstrates that: -
any differences do not raise new questions of safety and . effectiveness; and
-
the proposed devices are at least as safe and effective as the legally marketed predicate devices.
Substantial Equivalence Conclusion: