(104 days)
Not Found
No
The 510(k) summary describes a mechanical hip stem prosthesis and its intended use, design, and performance testing. There is no mention of AI or ML technology in the description of the device or its function.
Yes
The device, a total hip replacement prosthesis, is intended to alleviate pain, correct functional deformities, and restore function in patients with various joint conditions, which are therapeutic endpoints.
No
The device is a femoral hip stem intended for total hip replacement, which is a therapeutic device designed to alleviate pain and restore function, not to diagnose a condition.
No
The device description clearly describes a physical implant (femoral hip stem) made of metal, not software.
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 surgical implant for replacing a hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (femoral hip stem) made of specific materials and designed for surgical insertion. This is consistent with a medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The indications for use of the total hip replacement prostheses 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 and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Accolade II Femoral Stems with compatible Howmedica Oseonics 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.
Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LZO, LWJ, KWZ, KWY, KWL, JDI, LPH
Device Description
Howmedica Osteonics is introducing the Accolade II Femoral Hip Stem, a tapered non-porous coated femoral stem intended for cementless, press-fit application. The basic design of the Accolade II Femoral Hip Stem is similar to other total hip stems commercially distributed such as the Accolade TMZF Hip Stem. There are the design of the subject hip stem. such as a variable medial curvature which increases with each size in order to faciliate press fit stability and load transmission in the proximal region of the stem geometry is designed to address variations in patient femoral morphology. The overall stem length has been reduced, compared to the Accolade TMZF hip stem, to facilitate intra-operative stem insertion.
The stem is manufactured from a Ti-6Al-4V substrate materially Purc (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared 2 Piece Modular Hip Stem (K013106). The 2 Piece Modular Hip Stem (K013106) is now marketed and will be referred to throughout this submission as the Restoration Modular Hip Stem.
The Accolade II Femoral Hip Stem will be available in 12 sizes ranging from size 0 through 11 with two neck angles (127° and 132°) that provide dual head offsets. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. All instrumentation is listed in the Surgical Protocol attached.
The Accolade II Femoral Hip Stem is a sterile, single-use in primary and revision total hip arthroplasty to alleviate pain and restore function. The subject hip stem is compatible with V40 heads, C-1aper heads when used with the V40/C-Taper Adaptor Sleeve, Universal Heads when used with the V40/Universal Adaptor Sleeve and Unitrax Heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing bench testing was provided and included Range of Motion analysis, proximal fatigue, and distal fatigue testing. All of the observed results indicate that the Accolade II Hip System is substantially equivalent to devices currently marketed. Therefore, the subject device is as safet and effective, and performs at least as safely and effectively as legally marketed predicates identified.
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.
Accolade TMZF Hip Stem: K994366, K020572 & K023102, Restoration Modular Hip Stem: K013106
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
§ 888.3353 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
K103479
page 182
510(k) Summary
Proprietary Name:
Novel Tapered Hip Stem (aka Accolade II Femoral Hip Stem)
MAR 1 0 2011
Common Name: Hip prosthesis
Classification Name and Reference:
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888.3353
Regulatory Class: Class II
System Product Codes:
87 MEH - prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium-phosphate 87 LZO - prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
87 LWJ - prosthesis, hip, semi-constrained, metal/polymer, uncemented
- 87 K WZ prosthesis, hip, constrained, cemented or uncemented, metal/polymer
87 KWL - prosthesis, hip, hemi-, femoral, metal
87 KWY - Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
87 JDI - prosthesis, hip, semi-constrained, metal/polymer, cemented
87 LPH - prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
| Contact Person: | Estela Celi, Regulatory Affairs Associate |
|---|---|
| Howmedica Osteonics Corp. | |
| 325 Corporate Drive | |
| Mahwah, NJ 07430 | |
| Phone: (201) 831-6461 Fax: (201) 831-3461 |
Date Prepared: March 9, 2011
Legally Marketed Device to Which Substantial Equivalence is Claimed: Accolade TMZF Hip Stem: K994366, K020572 & K023102 Restoration Modular Hip Stem: K013106
Description:
Howmedica Osteonics is introducing the Accolade II Femoral Hip Stem, a tapered non-porous coated femoral stem intended for cementless, press-fit application. The basic design of the Accolade II Femoral Hip Stem is similar to other total hip stems commercially distributed such as the Accolade TMZF Hip Stem. There are the design of the subject hip stem. such as a variable medial curvature which increases with each size in order to faciliate press fit stability and load transmission in the proximal region of the stem geometry is designed to address variations in patient femoral morphology. The overall stem length has been reduced, compared to the Accolade TMZF hip stem, to facilitate intra-operative stem insertion.
The stem is manufactured from a Ti-6Al-4V substrate materially Purc (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared 2 Piece Modular Hip Stem (K013106). The 2 Piece Modular Hip Stem (K013106) is now marketed and will be referred to throughout this submission as the Restoration Modular Hip Stem.
The Accolade II Femoral Hip Stem will be available in 12 sizes ranging from size 0 through 11 with two neck angles (127° and 132°) that provide dual head offsets. The stem is designed for use with the currently available compatible Howmedica Osteonics' femoral heads and their compatible acetabular components. All instrumentation is listed in the Surgical Protocol attached.
The Accolade II Femoral Hip Stem is a sterile, single-use in primary and revision total hip arthroplasty to alleviate pain and restore function. The subject hip stem is compatible with V40 heads, C-1aper
1
page 2 of 2
heads when used with the V40/C-Taper Adaptor Sleeve, Universal Heads when used with the V40/Universal Adaptor Sleeve and Unitrax Heads.
Indications:
The indications for use of the total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 1)
- Rheumatoid arthritis 2)
-
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and, 4)
-
- Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Additional indication specific to use of Accolade II Femoral Stems 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,
Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty 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,
Technological Characteristics
The technological characteristics are basically the same as the predicates identified in the Legally Marketed Devices to which substantial equivalence is claimed with differences noted in design of the subject hip stem such as variable medial curvature, distal lateral reduction in overall stem length to accommodate various surgical approaches, specifically the direct approach. Stem lengths are within the range of legally marketed predicates.
Substantial Equivalence:
The Accolade II Femoral Hip Stem is substantially equivalent to other commercially available hip stems in regard to intended use, design, materials and operational principles as a hip prosthesis. The following devices are examples of predicate systems: Accolade TMZF Hip Stem and Restoration Modular Hip Stem. Based upon the mechanical testing, the Accolade II Femoral Hip Stem is substantially equivalent for its intended use to other press-fit femoral replacement hip stems currently on the market.
Summary of Non-Clinical Testing:
Non-clinical testing bench testing was provided and included Range of Motion analysis, proximal fatigue, and distal fatigue testing. All of the observed results indicate that the Accolade II Hip System is substantially equivalent to devices currently marketed. Therefore, the subject device is as safective, and performs at least as safely and effectively as legally marketed predicates identified.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized representation of the body and legs.
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR 2 1 2011
Howmedica Osteonics Corp. % Ms. Estela Celi Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430
Re: K103479
Trade/Device Name: Novel Tapered 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: MEH, LZO, LWJ, KWZ, KWY, KWL, JDI, LPH Dated: February 18, 2011 Received: February 22, 2011
Dear Ms. Celi:
This letter corrects our substantially equivalent letter of March 10, 2011. 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 (PMA). Vo 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.
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 af the Act
3
Page 2 - Ms. Estela Celi
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/CDRHODRHOffices/uccn1118800.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" (21 CCFR Previous 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 yours,
A.J. V.S. D. te
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K103479
Device Name: Novel Tapered Hip Stem (aka Accolade II Femoral Hip Stem)
Indications for Use:
The indications for use of the total hip replacement prostheses include:
- Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 1)
- Rheumatoid arthritis 2)
- Correction of functional deformity; 3)
- Revision procedures where other treatments or devices have failed; and, 4)
- Nonunions, femoral neck and trochanies of the proximal femur with head involvement that are unmanageable રે) using other techniques.
Additional indication specific to use of Accolade II Femoral Stems with compatible Howmedica Oseonics Constrained Liners:
- When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use l. in primary or revision patients at hip distocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.
Accolade II Femoral Stems are intended for cementless use only and and hemiarthroplasty procedures.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M. Makerson
(Division Sign Only)
Division of Syrgical, Orthopedic, and Restorative Devices
510(k) Number K103479