(268 days)
No
The document describes a mechanical hip stem and its materials, design, and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is intended for use in total and hemi-hip arthroplasty to alleviate pain and restore function, which are therapeutic goals.
No
This device is a hip stem intended for surgical implantation, not for diagnosing conditions.
No
The device description clearly states it is a monolithic, non-porous coated femoral hip prosthesis made from titanium alloy, with physical features like normalization patterns and a shot peened neck. This describes a physical implant, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "primary and revision total and hemi-hip arthroplasty to alleviate pain and restore function." This describes a surgical implant used directly in the body for treatment.
- Device Description: The description details a "monolithic, non-porous coated femoral hip prosthesis," which is a physical implant.
- Lack of IVD Characteristics: The text does not mention any of the characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in vitro (outside the living body).
The Anato™ Hip Stem is a medical device, specifically a surgical implant.
N/A
Intended Use / Indications for Use
The Anato™ Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi-hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' V40™ femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40130 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40™ CoCr Heads, V40™ LFITM CoCr Heads, C-Taper Alumina Heads when used with the V40TM /C-taper Adapter, C-Taper Delta Heads when used with C-taper Adaptor, UHR® Universal Head, Unitrax® Heads when used with the Unitrax® V40™ Modular Adapter.
The indications for use for total hip arthroplasty include:
- noninflammatory degenerative joint disease, including osteoarthritis . and avascular necrosis;
- rheumatoid arthritis; .
- correction of functional deformity; .
- revision procedures where other treatments or devices have failed; and, ●
- nonunions, femoral neck fractures, and trochanteric fractures of the . proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Anato™ Hip Stem with compatible Howmedica Osteonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics . Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.
Product codes
MAY, LZO, MEH, LPH, MBL
Device Description
Howmedica Osteonics is introducing a monolithic, non-porous coated femoral hip prosthesis, which is intended for cementless, press-fit application. The basic design of the Anato™ Hip Stem is similar to two other commerically distributed total hip systems, which are Howmedica Osteonics' ABG® II Monolithic and Accolade® II Hip Stems.
The Anato™ and the Accolade® II stem are both made from the same material combinations. The subject device is similar in design to the ABG® II Monolithic stem as they are both anatomic stems with a 130 degree neck angle. There are normalization patterns (scales) on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission. Based on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.
The subject stem is manufactured from titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium coating, and PureFix® hydroxylapatite (HA) coating identical to the previously cleared Accolade® II Hip Stem.
The Anato™ Hip Stem has a shot peened neck and will be available in 8 sizes ranging from size 1 through 8 with two different neck versions (neutral and anteverted). As the stem is anatomic, there will be a right and left component for each size. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, proximal femur
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
Non-Clinical Testing:
- 1 ) Distal Stem Fatigue Testing in compliance with ISO 7206-4
-
- Neck Fatigue Testing in compliance with ISO 7206-6
The results of the above testing verify that the new device is substantially equivalent to devices currently cleared for marketing.
- Neck Fatigue Testing in compliance with ISO 7206-6
Clinical Testing:
Clinical testing was not required as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
| 510(k) Summary | |||
|---|---|---|---|
| Sponsor: | Howmedica Osteonics Corp. | ||
| 325 Corporate Drive | |||
| Mahwah, NJ 07430 | |||
| Contact Person: | Colleen Burdel | ||
| Regulatory Affairs Associate | |||
| t. 201-831-5969 | |||
| f. 201-831-4969 | |||
| Date Prepared: | November 20 , 2012 | ||
| Proprietary Name: | ABG® III Monolithic Hip Stem (also known as | ||
| Anato™ Hip Stem) | |||
| Common Name: | Hip prosthesis | ||
| Classification Name and Reference: | Hip joint metal/ceramic/polymer semi-constrained | ||
| cemented or nonporous uncemented prosthesis, 21 | |||
| CFR §888.3353 (Product Codes MAY, LZO, MEH) | |||
| Hip joint metal/polymer/metal semi-constrained | |||
| porous coated uncemented prosthesis, 21 CFR | |||
| §888.3358 (Product Codes LPH, MBL) | |||
| Legally Marketed Device to Which Substantial Equivalence is Claimed: | |||
| ABG® II Monolithic Hip Stem | K110807 |
| ABG® II Monolithic Hip Stem | K110807 |
|---|---|
| Accolade® II Hip Stem | K103479, K120578 |
Device Description:
Howmedica Osteonics is introducing a monolithic, non-porous coated femoral hip prosthesis, which is intended for cementless, press-fit application. The basic design of the Anato™ Hip Stem is similar to two other commerically distributed total hip systems, which are Howmedica Osteonics' ABG® II Monolithic and Accolade® II Hip Stems.
The Anato™ and the Accolade® II stem are both made from the same material combinations. The subject device is similar in design to the ABG® II Monolithic stem as they are both anatomic stems with a 130 degree neck angle. There are normalization patterns (scales) on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission. Based on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.
The subject stem is manufactured from titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium coating, and PureFix® hydroxylapatite (HA) coating identical to the previously cleared Accolade® II Hip Stem.
The Anato™ Hip Stem has a shot peened neck and will be available in 8 sizes ranging from size 1 through 8 with two different neck versions (neutral and anteverted). As the stem is anatomic, there will be a right and left component for each size. The stem is designed only for
1
use with compatible Howmedica Osteonics' femoral heads and acetabular components.
Intended Use:
The Anato™ Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi-hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' V40™ femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40130 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40™ CoCr Heads, V40™ LFITM CoCr Heads, C-Taper Alumina Heads when used with the V40TM /C-taper Adapter, C-Taper Delta Heads when used with C-taper Adaptor, UHR® Universal Head, Unitrax® Heads when used with the Unitrax® V40™ Modular Adapter.
Indications:
The indications for use for total hip arthroplasty include:
- noninflammatory degenerative joint disease, including osteoarthritis . and avascular necrosis;
- rheumatoid arthritis; .
- correction of functional deformity; .
- revision procedures where other treatments or devices have failed; and, ●
- nonunions, femoral neck fractures, and trochanteric fractures of the . proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Anato™ Hip Stem with compatible Howmedica Osteonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics . Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.
Summary of Technologies:
Device comparison and mechanical testing showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices.
Non-Clinical Testing:
The following tests were conducted:
- 1 ) Distal Stem Fatigue Testing in compliance with ISO 7206-4
-
- Neck Fatigue Testing in compliance with ISO 7206-6
The results of the above testing verify that the new device is substantially equivalent to devices currently cleared for marketing.
Clinical Testing:
Clinical testing was not required as a basis for substantial equivalence.
2
.
:
Conclusion:
. .
·
. . . .
:
The Anato™ Hip Stem is substantially equivalent to the predicate devices identified in this premarket notification.
. . . .
.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 16, 2013
Ms. Colleen Burdel Regulatory Affairs Associate Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K123604
Trade/Device Name: ABG III Monolithic Hip Stem (also known as Anato™ Hip Stem) 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: MAY. LZO, MEH, LPH, MBL Dated: July 15, 2013 Received: July 16, 2013
Dear Ms. Burdel:
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 10 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: CDRII 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
4
Page 2 – Ms. Colleen Burdel
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely vours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K123604
Device Name: ABG® III Monolithic Hip Stem (also known as Anato™ Hip Stem)
The indications for use for total hip arthroplasty include:
-
- noninflammatory degenerative joint disease, including
- osteoarthritis and avascular necrosis;
-
- rheumatoid arthritis;
-
- correction of functional deformity;
-
- revision procedures where other treatments or devices have failed; and.
-
- nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Anato™ Hip Stem with compatible Howmedica Osteonics Constrained Liners:
-
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
The Anato™ Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices