(316 days)
The Taperloc® Complete Hip Stems are intended for hip joint arthroplasty.
- 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.
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 document provided is a 510(k) premarket notification for the Taperloc® Complete Hip Stems. It describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a formal table with pass/fail thresholds for the tests conducted. Instead, it states that "All testing passed and met the specifications or comparison testing (as applicable) to the predicate devices." This implies that the acceptance criteria were either established by the referenced ASTM standards or through direct comparison to the performance of the predicate device.
| Test Performed | Standard / Comparison Basis | Reported Device Performance |
|---|---|---|
| Porous Plasma Spray Coating Testing: | ||
| Tensile | ASTM 1147 | Passed and met specifications or comparison to predicate |
| Fatigue | ASTM F1160 | Passed and met specifications or comparison to predicate |
| Porosity | ASTM F1854 | Passed and met specifications or comparison to predicate |
| Pore Size | ASTM F1854 | Passed and met specifications or comparison to predicate |
| Thickness | ASTM F1854 | Passed and met specifications or comparison to predicate |
| Tabor Abrasion | ASTM F1978 | Passed and met specifications or comparison to predicate |
| Shear Fatigue | ASTM F1160 | Passed and met specifications or comparison to predicate |
| Shear Static | ASTM F1044 | Passed and met specifications or comparison to predicate |
| Roughness | Comparison to predicate | Passed and met specifications or comparison to predicate |
| One-Step Forging Distal Pot Up/Down Fatigue Testing: | ||
| Rotating Beam Fatigue | ASTM STP 731 | Passed and met specifications and comparison to predicate device |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions "samples" for the porous plasma spray coating testing and "samples" for the one-step forging distal pot up/down fatigue testing. However, specific numerical sample sizes are not provided for any of these non-clinical tests.
- Data Provenance: The document states these are "Non-Clinical Tests" performed to support the 510(k) submission. It does not specify the country of origin where the testing was conducted. It is inherently prospective in the sense that the tests were performed specifically for this regulatory submission to evaluate the cumulative changes to the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a medical device, specifically an orthopedic implant (hip stem), and the performance data is entirely non-clinical (mechanical and material testing). Therefore, there were no human experts involved in establishing ground truth in the traditional sense of clinical or diagnostic studies. The "ground truth" for these engineering tests would be established by the testing protocols and the objective measurements themselves, adhering to the specified ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As stated above, these are non-clinical, objective engineering tests, not clinical evaluations requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes a medical device (hip implant), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the objective measurements obtained through adherence to the specified ASTM standards and direct comparison to the predicate device's performance. There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical mechanical tests.
8. The sample size for the training set
Not applicable. There is no "training set" as this is a physical medical device and the studies refer to non-clinical material and manufacturing process changes, not machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned or implied.
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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
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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 Orthopedic56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034 | Primary Predicate | 510(k) Number |
|---|---|---|---|
| Primary ContactPerson: | Genoa AtwoodRegulatory Affairs Sr. SpecialistTelephone: (864) 553-9153 | Taperloc® Complete Hip Stems | K101086 |
| Secondary ContactPerson: | Rhonda MyersRegulatory Affairs Sr. Project ManagerTelephone: (574) 373-9659 | ||
| Date: | January 2, 2020 | ||
| Subject Device: | Trade Name: Taperloc® Complete Hip StemsCommon Name: Uncemented porous modular hip prosthesis | ||
| Classification Name: | • LZO - Hip joint metal/ceramic/polymer semi constrainedcemented or nonporous uncemented prosthesis (21CFR 888.3353)• KWZ- Hip joint metal/polymer constrained cementeduncemented prosthesis (21 CFR 888.3310)• JDI - Hip joint metal/polymer semi-constrained cementedprosthesis (21 CFR 888.3350)• MAY- Hip joint metal/ceramic/polymer semi- constrainedcemented or nonporous uncemented prosthesis (21CFR 888.3353)• MEH- Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis (21CFR 888.3353)• LPH - Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis (21 CFR888.3358)• KWL- Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis (21 CFR 888.3360)• KWY- Hip joint femoral (hemi-hip) metal/polymer cementedor uncemented prosthesis (21 CFR 888.3390) |
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Predicate Device:
| Purpose and DeviceDescription: | Taperloc® Complete Hip Stems are used for hip arthroplasty. |
|---|---|
| Taperloc® Complete Hip Stems are an implant device, a porouscoated femoral stem intended for uncemented biological fixation.The Taperloc® Complete is a series of hip stems with a bi-planarwedge design, titanium substrate, and proximally circumferentialtitanium porous plasma sprayed design. | |
| The purpose of this submission is:• To submit a 510(k) for cumulative changes made to the systemsince original clearance;○ The distal profile of the Taperloc Complete 9mm ReducedDistal Profile hip stems was reduced in diameter,○ The Porous Plasma Spray Process was changed to anautomatic process,○ The manufacturing process was changed from a doubleforging process step to a single-forging step. | |
| Intended Use and | The Taperloc® Complete Hip Stems are intended for hip jointarthroplasty. |
| Indications for Use: | 1. Non-Inflammatory degenerative joint disease includingosteoarthritis and avascular necrosis.2. Rheumatoid arthritis.3. Correction of functional deformity.4. Treatment of non-union. Femoral neck fracture, and trochantericfractures of the proximal femur with head involvement,unmanageable by other techniques.5. Revision procedures where other treatment or devices have failedPorous coated components are intended for uncemented biologicalfixation. |
| Summary ofTechnologicalCharacteristics: | The rationale for substantial equivalence is based on consideration ofthe 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 |
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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:
§ 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.