(22 days)
Not Found
No
The document describes a hip stem and its intended use, focusing on material and design. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is a total hip component used in surgery to rehabilitate damaged hips, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
This device is a total hip component, which is an implant used in surgery to replace damaged hips. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "fully porous coated HA stem," which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided text describes a total hip component, specifically a femoral stem, which is an implantable device used in hip replacement surgery.
- Intended Use: The intended use clearly states that the device is used in individuals undergoing surgery to replace damaged hip joints. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Total hip components are indicated uncemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as theumatoid arthritis; or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Echelon Porous Plus HA Hip Stems are designed uncemented use and for single use only.
Product codes (comma separated list FDA assigned to the subject device)
MEH
Device Description
Echelon Porous Plus HA Hip Stems are fully porous coated HA stems. These stems are designed for use with existing modular Smith & Nephew, Inc. femoral heads.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Design Verification Test results indicate that the subject devices meet the requirements of the applicable FDA guidance documents.
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.
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
510(k) Summary Echelon Porous Plus HA Hip Stems
OCT 2 5 2002
| Submitter's name: | Smith & Nephew, Inc. |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901-399-6487 |
| Contact person: | David Henley |
| Date summary prepared: | October 22, 2002 |
| Trade or proprietary device name: | Echelon Porous Plus HA Hip Stems |
| Common or usual name: | Prosthetic Hip Joint - HA Coated Porous Femoral Stem |
| Device Product Code and Panel Code: | MEH / 87 (Orthopedics) |
| Classification name: | 21 CFR 888.3358 hip joint metal/polymer/metal semi- |
| constrained porous-coated uncemented prosthesis-Class II |
Substantially Equivalent Legally Marketed Devices
Echelon Porous Plus HA Hip Stems are substantially equivalent to Smith & Nephew Synergy HA on Porous Hip Stems (K002996), Howmedica Meridian ST/PA Femoral Stems (K971206) and Osteomplant Technology, Inc. LSF HA Coated Triad Total Hip System (femoral stems).
Device Description
Echelon Porous Plus HA Hip Stems are fully porous coated HA stems. These stems are designed for use with existing modular Smith & Nephew, Inc. femoral heads.
Device Intended Use
Total hip components are indicated uncemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as theumatoid arthritis; or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Echelon Porous Plus HA Hip Stems are designed uncemented use and for single use only.
Technological and Performance Characteristics:
Echelon Porous Plus HA Hip Stems are similar to and substantially equivalent to the legally marketed predicate devices listed previously. All of these predicate devices are indicated for total hip replacement, are similar in design, and have the same technological characteristics as Echelon Porous Plus HA Hip Stems. The safety and effectiveness for the subject devices is adequately supported by test data, material information, and substantial equivalence information provided in this Special 510(k) Premarket Notification. Design Verification Test results indicate that the subject devices meet the requirements of the applicable FDA guidance documents.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines above it, representing the department's mission to promote health and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CT 2 5 2002
Mr. David Henlev Senior Clinical/Regulatory Affairs Specialist Smith and Nephew, Inc. 1450 E. Brooks Road Memphis. Tennessee 38116
Re: K023302
Trade/Device Name: Echelon Porous Plus HA 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: MEH Dated: October 2, 2002 Received: October 3, 2002
Dear Mr. Henley:
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,
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.
2
Page 2 - Mr. David Henley
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
R-Mach A. Mallean
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Premarket Notification Indications Statement
510(k) Number (if known): KO23302
Device Name: Echelon Porous Plus HA Hip Stems
Indications for Use:
Total hip components are indicated for uncemented use only in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free persod; non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.
Echelon Porous Plus HA Hip Stem components are intended uncemented use and for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Madk. N. Milhiner.
(Division Sion-Off) Division of General, Restorative and Neurological Devices
510(k) Number ___ K(0.2)330
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use (Optional Format 1-2-96)