(29 days)
No
The summary describes a hip replacement system and its components, focusing on materials, design features, and mechanical performance testing. There is no mention of AI or ML technology.
Yes
The device, an Exactech Hip System, is indicated for use in treating various conditions like osteoarthritis, rheumatoid arthritis, and osteonecrosis, which are diseases or disorders. It also aims to restore mobility, indicating a therapeutic effect.
No
The device is a component of a hip replacement system, indicated for surgical implantation to treat various hip conditions, not for diagnosing them.
No
The device description clearly outlines physical components (femoral heads, adapters, stems, liners) made of materials like ceramic and titanium alloy, and the performance studies involve engineering evaluations of physical properties like strength and fatigue. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical hip replacement. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as femoral heads and adapters, which are components of a hip implant system. These are physical implants, not reagents, instruments, or software used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on bodily fluids or tissues, or providing diagnostic information based on such analysis.
The device is a surgical implant used to replace a damaged hip joint.
N/A
Intended Use / Indications for Use
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
- Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
Product codes
LZO
Device Description
The proposed Exactech BIOLOXdelta femoral heads and Biolox Option femoral heads and adapters are modifications to the existing Exactech 12/14 Alumina heads previously cleared in K032964 and K051682. The proposed femoral heads and adapters have the same general design features as the predicate device. The proposed femoral heads are manufactured from an alumina/zirconia based ceramic material known as Delta per ISO 6474-2. The Biolox Option adapters are comprised of titanium alloy per ISO 5832-3 and are intended for use with the Biolox Option femoral heads for primary and revision applications in which the taper remains intact.
The proposed femoral heads mate with the following devices:
- 12/14 Femoral Stems
- 0 Novation Press-Fit Femoral Stems (K042842)
- Novation Splined RDD Femoral Stem (K063279) o
- o Novation Element Press-Fit Femoral Stem (K080980)
- Novation Cemented Stems (K052787) O
- Novation Cemented Plus (K083392) O
- AcuMatch Press Fit Stems (K041906, K051335) 0
- AcuMatch Cemented Stems (K052787)
- AcuMatch M-Series (K032964, K051858) O
- Acetabular Liners .
- Novation Crown Cup Standard and GXL UHMWPE Liners (K070479, K100269) o
- Novation Crown Cup Constrained Liners (K071676) o
- AcuMatch A-Series Standard and GXL UHMWPE Liners (K993082, K000242, o K040613, K051556)
- AcuMatch Constrained Liners (K040601) o
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- similar indications for use
- similar design features
- incorporate similar materials
- the same shelf life
- are packaged and sterilized using the same materials and processes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
Indicated Patient Age Range
Skeletally mature individuals
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 following engineering evaluations were conducted to demonstrate substantial equivalence of the proposed devices to the predicate devices:
- Burst strength (ISO-7206-10)
- Fatigue strength (ISO-7206-10)
- Post fatigue strength(ISO-7206-10)
- Pull off force and Torque (Ceramtec specifications and FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems)
Results of engineering analyses referenced in this 510(k) submission demonstrate that the proposed Bioloxdelta femoral heads and Biolox Option femoral heads and adapters are substantially equivalent to the cleared predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
K.10301d *"1/3
BIOLOX® Delta and BIOLOX® Option Femoral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness
| Company: | Exactech, Inc.
2320 N.W. 66th Court
Gainesville, FL 32653 |
|-----------------|-----------------------------------------------------------------|
| | Phone: (352) 377-1140
Fax: (352) 378-2617 |
| Contact Person: | Lindy Knisely |
Date: November 10, 2010
II. Proprietary Name:
I.
Exactech BIOLOX®Delta Femoral Heads and BIOLOX® Option Femoral Heads and Adapters
Common Name: Femoral Head
Classification Name:
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-● Porous, Uncemented
Legally Marketed Devices to Which Substantial Equivalence Is Claimed: III.
| 510(k) Number | Trade of Proprietary Model Name | Manufacturer |
|---|---|---|
| K032964 | Exactech 12/14 Alumina Femoral Heads | Exactech, Inc |
| K051682 | Exactech 12/14 Alumina Femoral Heads 36mm | Exactech, Inc |
IV. Indications for Use:
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for cemented . fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-. fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
NOV 1 0 2010
1
K10301d #2/3
BIOLOX® Delta and BIOLOX® Option Femoral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness
- Femoral heads and endoprostheses are intended for use in cemented and press-fit . applications.
V. Device Description
The proposed Exactech BIOLOXdelta femoral heads and Biolox Option femoral heads and adapters are modifications to the existing Exactech 12/14 Alumina heads previously cleared in K032964 and K051682. The proposed femoral heads and adapters have the same general design features as the predicate device. The proposed femoral heads are manufactured from an alumina/zirconia based ceramic material known as Delta per ISO 6474-2. The Biolox Option adapters are comprised of titanium alloy per ISO 5832-3 and are intended for use with the Biolox Option femoral heads for primary and revision applications in which the taper remains intact.
The proposed femoral heads mate with the following devices:
- . 12/14 Femoral Stems
- 0 Novation Press-Fit Femoral Stems (K042842)
- Novation Splined RDD Femoral Stem (K063279) o
- o Novation Element Press-Fit Femoral Stem (K080980)
- Novation Cemented Stems (K052787) O
- Novation Cemented Plus (K083392) O
- AcuMatch Press Fit Stems (K041906, K051335) 0
- AcuMatch Cemented Stems (K052787) ಂ
- AcuMatch M-Series (K032964, K051858) O
- Acetabular Liners .
The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:
- . similar indications for use
- similar design features .
- . incorporate similar materials
- . the same shelf life
- are packaged and sterilized using the same materials and processes
Summary of Non-Clinical Performance Data VI.
The following engineering evaluations were conducted to demonstrate substantial equivalence of the proposed devices to the predicate devices:
2
K10301d*#3)3
BIOLOX® Delta and BIOLOX® Option Femoral Heads Special 510(k) - 510(k) Summary of Safety and Effectiveness
- . Burst strength (ISO-7206-10)
- . Fatigue strength (ISO-7206-10)
- Post fatigue strength(ISO-7206-10) .
- Pull off force and Torque (Ceramtec specifications and FDA Guidance Document . for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems)
VII. Substantial Equivalence Conclusion:
| Device Comparison | Predicate | Proposed |
|---|---|---|
| Femoral Head | 12/14 Alumina Femoral | |
| Heads | Bioloxdelta Femoral Heads | |
| Biolox Option Femoral Heads | ||
| and Adapters | ||
| Manufacturer | Exactech, Inc | |
| Intended Use | Primary Hip Arthroplasty | Bioloxdelta: Primary Hip |
| Athroplasty | ||
| Biolox Option: Primary or | ||
| Revision Hip Arthroplasty | ||
| Indications for Use | Similar indications for use | |
| Stem Compatibility | 12/14 Ti-6Al-4V or CoCr Tapers with geometry to accept | |
| ceramic head | ||
| Material Composition | Conforms to recognized industry standards and requirements | |
| Taper Bore Geometry | Similar geometry to be compatible with 12/14 trunnions | |
| Head OD Sizes | Same OD size range | |
| Head Offset Sizes | -3.5mm, +0mm, +3.5mm | -3.5mm, +0mm, +3.5mm, |
| +7mm | ||
| Sterile Barrier | ||
| Packaging | Same packaging materials | |
| Sterilization | Same sterilization method |
Results of engineering analyses referenced in this 510(k) submission demonstrate that the proposed Bioloxdelta femoral heads and Biolox Option femoral heads and adapters are substantially equivalent to the cleared predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Exactech, Inc. % Ms. Lindy Knisely, R.N. Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653
NOV 1 0 2010
Re: K103012 Trade/Device Name: BIOLOX® Delta Femoral Heads and BIOLOX® Option Femoral Heads and Adapters 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 Dated: October 8, 2010 Received: October 12, 2010
Dear Ms. Knisely:
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.
4
Page 2 - Ms. Lindy Knisely
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 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
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
BIOLOX® Delta and BIOLOX® Option Femoral Heads Special 510(k) - Indications for Use
KIDSOLA 510(k) Number:
NOV 1 0 2010
Device Name: BIOLOX® Delta Femoral Heads and BIOLOX® Option Femoral Heads and Adapters
Indications:
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- . Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
- t Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon
- . Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.
| Prescription Use _X | and/or | Over-The-Counter Use_ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
Please do not write below this line - use another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Janeta de der mxm
Division of Surgical and Restorative Devices
510(k) Number K103012