(226 days)
The Echelon Titanium Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively, treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The Echelon Titanium Hip System is intended for single use only and implanted without bone cement.
The body of the Echelon Titanium Hip System femoral stems is similar in shape to the Anthology Hip Stem as previously cleared under premarket notification K052792. The material, porous coating and surface finish of the Echelon Titanium Hip System femoral stems are identical to the Anthology Hip Stem (K052792). The Echelon Titanium Hip System femoral stems are offered in primary and revision options featuring a 10/12 neck taper for use with the 10/12 Taper Femoral Heads.
This 510(k) summary for the SMITH & NEPHEW ECHELON TITANIUM HIP SYSTEM does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through testing or clinical trials.
Instead, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the device is deemed safe and effective because it has similar design features, overall indications for use, and material composition to devices already cleared by the FDA.
Therefore, for your request, I must report that the requested information is not present in the provided document.
Here's why and what's typically expected in such a request:
- Acceptance Criteria & Reported Device Performance: This document does not specify any measurable performance metrics (e.g., tensile strength, fatigue life, wear rates, clinical success rates, etc.) that the Echelon Titanium Hip System was tested against to establish "acceptance criteria" for a new, novel device.
- Study That Proves the Device Meets Acceptance Criteria: There is no mention of any study (e.g., in-vitro bench testing, animal studies, human clinical trials) specifically designed to demonstrate the performance of the Echelon Titanium Hip System. The entire basis for clearance is the comparison to predicate devices, implying that the established performance of those predicates effectively "proves" the new device's suitability due to its similarity.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all concepts related to the evaluation of diagnostic algorithms or complex AI systems, or performance studies that involve human interpretation or complex data analysis. For a medical device like a hip implant seeking 510(k) clearance based on substantial equivalence, these types of detailed study methodologies are generally not required or presented in the summary unless there are novel aspects requiring such investigation (e.g., new materials, entirely new design principles, or specific performance claims that deviate from predicates).
Conclusion:
The provided 510(k) summary focuses entirely on establishing substantial equivalence for a hip implant system. It explicitly states: "The substantial equivalence of the Echelon Titanium Hip System is supported by its similarities in design features, overall indications, and material composition to table of legally marketed devices for total hip replacement." It also mentions: "The intended use, design, and materials of the Echelon Titanium Hip System are similar to the legally marketed devices listed above."
Therefore, I cannot extract the requested information from this document. The "study" proving the device meets acceptance criteria, in this context, is the comparison to legally marketed predicate devices.
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510(K) SUMMARY SMITH & NEPHEW ECHELON TITANIUM HIP SYSTEM
MAY 1 5 2008
| SUBMITTER'S NAME: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| SUBMITTER'S ADDRESS: | 1450 Brooks Road, Memphis, TN 38116 |
| SUBMITTER'S TELEPHONE NUMBER: | 901-399-6055 |
| CONTACT PERSON: | Marlon D. Ridley |
| DATE SUMMARY PREPARED: | January 16, 2008 |
| TRADE OR PROPRIETARY DEVICE NAME: | Echelon Titanium Hip System |
| COMMON OR USUAL NAME: | Prosthetic Hip Joint System-Porous Femoral Stem |
| CLASSIFICATION NAME AND REFERENCE: | 21 CFR 888.3358 Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis - Class II21 CFR 888.3350 Hip Joint Metal/Polymer Semi-ConstrainedCemented Prosthesis - Class II21 CFR 888.3353 Hip Joint Metal/Ceramic/Polymer Semi-Constrained - Class II21 CFR 878.3300 Surgical Mesh - Class II |
| PRODUCT CODE AND PANEL CODE: | Orthopaedics 87 / LPH / MBL / MEH / JDI / JDJ |
PRC
DEVICE INFORMATION:
प्र INTENDED USE:
The Echelon Titanium Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips clamaged as a result of Irauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively, treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteolorny, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
The Echelon Titanium Hip System is intended for single use only and implanted without bone cement.
ന് DEVICE DESCRIPTION:
The body of the Echelon Titanium Hip System femoral stems is similar in shape to the Anthology Hip Stem as previously cleared under premarket notification K052792. The material, porous coaling and surface finish of the Echelon Titanium Hip System fernoral stems are identical to the Anthology Hip Stern (K052792). The Echelon Titanium Hip System femoral stems are offered in primary and revision options featuring a 10/12 neck taper for use with the 10/12 Taper Femoral Heads.
SUBSTANTIAL EQUIVALENCE INFORMATION: ﻝ
The substantial equivalence of the Echelon Thanium Hip System is supported by II's Similarities in design features, overall indications, and material composition to table of legally marketed devices for total hip replacement.
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| COMPANY | PREDICATE DEVICE NAME | 510(κ) | CLEARANCEDATE |
|---|---|---|---|
| Smith & Nephew, Inc. | ANTHOLOGY® Hip Stems | K052792 | 10/07/2005 |
| Wright MedicalTechnology, Inc. | Profemur Renaissance Total Hip System | K051995 | 08/22/2005 |
| Ortho DevelopmentCorporation | Encompass Cemented Hip Stem and 10/12 CobaltChrome Heads | K050637 | 09/23/2005 |
| Smith & Nephew, Inc. | Global Taper Tapered Hip System | K963509 | 01/27/1997 |
| Smith & Nephew, Inc. | Hip Joint Prosthesis (Richards Modular Hip System) | K924100 | 04/02/1993 |
SUMMARY OF TECHNOLOGICAL COMPARISON: D.
The intended use, design, and materials of the Echelon Titanium Hip System are similar to the legally marketed devices listed above. The Echelon Titanium Hip System components have the same technological characteristics as each of the legally marketed devices listed above as indicated for total hip replacement.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and tail. The eagle's head is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Mr. Jason Sells Project Manager, Regulatory Affairs 1450 Brooks Road Memphis, TN 38116
K072817 Re: Trade/Device Name: Echelon Titanium Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, MBL, JDI, MEH, JDJ Dated: May 12, 2008 Received: May 13, 2008
Dear Mr. Sells:
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.
MAY 15 2008
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Jason Sells
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mullison
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Smith&nephew
Indications for Use
一次不可是
510(k) Number (if known):
Device Name: Echelon Titanium Hip System
Indications for Use:
The Echelon Titanium Hip System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have falled in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID)D) or any of its composite diagnoses of osteoarthrilis, avascular necrosis, traumatic anhrifis slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including theumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochariteric fractures of the proximal fernur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osfeotomy, or Girdlestone resection; fracture distocation of the hip; and correction of deformity.
The Echelon Titanium Hip System is intended for single use only and implanted vittho bone cement
Prescription Use IPart 21 CFR 801 Subpart Di
Over-The-Counter Use AND/OR 21 CFR 807 Subpan CI
IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
DRH, Office of Device Evaluation (ODE) Concurrance of
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K072817
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.