(112 days)
No
The document describes a mechanical hip stem and its intended use 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 a hip stem used in primary and revision surgery for various hip conditions, clearly indicating a therapeutic purpose.
No
This device is a hip stem (implant) used in primary and revision surgery to replace damaged hips. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is a femoral hip stem, which is a physical implant made of titanium alloy. It also describes mechanical testing of the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic or monitoring purposes.
- Device Description and Intended Use: The provided text clearly describes a hip stem, which is an implantable medical device used in hip replacement surgery. Its intended use is to replace damaged parts of the hip joint in individuals undergoing primary and revision surgery.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from the patient. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the SLR-PLUS Hip Stem is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SLR-PLUS Hip Stem is indicated for uncemented use 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 (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. Smith & Nephew Orthopaedics AG SLR-PLUS Hip Stems are intended for single use only.
Product codes
LZO, LPH, MBL, MEH, JDI, JDJ
Device Description
Subject of this Traditional 510(k) premarket notification is the SLR-PLUS Standard and Lateral Femoral Stems. The subject devices are intended for primary hip arthroplasties and to replace previously failed femoral hip arthroplasties. The SLR-PLUS Standard Femoral Stems are designed for prosthetic arthroplasty in primary and revision surgery. The SLR-PLUS Lateral stem has been designed to optimize the lateralization of the femur (offset) in hip arthroplasty surgery. Both stems are manufactured from Ti-6Al-7Nb titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips, femoral, 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
The following tests were used as a basis for the determination of substantial equivalence:
- Neck fatigue testing per ASTM F 2068-03 and ISO 7206-6.
- Distal fatigue testing per ISO 7206-4/8.
- Range of Motion per EN ISO 21535.
Key Metrics
Not Found
Predicate Device(s)
Smith & Nephew Orthopaedics AG SL-PLUS Standard and Lateral Hip Stems (K072852), Smith & Nephew Anthology Hip Stem (K052792), SL-PLUS AND SLR-PLUS Stems (K001942)
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.
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p. 1/2
510(k) Summary
Ve are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116
APR 1 5 2010 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | April 8, 2010 |
| Contact Person and Address: | Shereen Myers, Regulatory Affairs Specialist
T (901) 399-6325 F (901) 566-7075 |
| Name of Device: | Smith & Nephew Orthopaedics AG SLR-PLUS Standard and
Lateral Femoral Stems |
| Common Name: | Hip Stem |
| Device Classification Name and
Reference: | 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-
constrained cemented or nonporous uncemented
prosthesis
21 CFR 888.3358 Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented prosthesis
21 CFR 878.3300 Surgical mesh
21 CFR 888.3350 Hip joint metal/polymer semi-constrained
cemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LZO, subsequent LPH, MBL, MEH, JDI, JDJ |
Device Description
Subject of this Traditional 510(k) premarket notification is the SLR-PLUS Standard and Lateral Femoral Stems. The subject devices are intended for primary hip arthroplasties and to replace previously failed femoral hip arthroplasties. The SLR-PLUS Standard Femoral Stems are designed for prosthetic arthroplasty in primary and revision surgery. The SLR-PLUS Lateral stem has been designed to optimize the lateralization of the femur (offset) in hip arthroplasty surgery. Both stems are manufactured from Ti-6Al-7Nb titanium alloy.
Technological Characteristics
A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure.
Intended Use
The SLR-PLUS Hip Stem is indicated for uncemented use 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 (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
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510(k) Summary
p.2/2
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. Smith & Nephew Orthopaedics AG SLR-PLUS Hip Stems are intended for single use only.
Substantial Equivalence Information
The substantial equivalence of the SLR-PLUS Femoral Stems is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate systems:
- Smith & Nephew Orthopaedics AG SL-PLUS Standard and Lateral Hip Stems (K072852) .
- Smith & Nephew Anthology Hip Stem (K052792) .
- SL-PLUS AND SLR-PLUS Stems (K001942) .
The following tests were used as a basis for the determination of substantial equivalence:
- Neck fatigue testing per ASTM F 2068-03 and ISO 7206-6 .
- Distal fatigue testing per ISO 7206-4/8 .
- Range of Motion per EN ISO 21535 .
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. Orthopaedic Division % Ms. Shereen Myers Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116
APR 1 5 2010
Re: K093991
Trade/Device Name: SLR-PLUS Standard and Lateral Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, LPH, MBL, MEH, JDI, JDJ Dated: April 8, 2010 Received: April 9, 2010
Dear Ms. Myers:
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.
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
3
Page 2 - Ms. Shereen Myers
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 (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 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 mav 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.
Sincerest yours,
Mark A. Milliceres
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
510(k) Number (if known): K093991
Device Name: SLR-PLUS Standard and Lateral Femoral Stems
Indications for Use:
The SLR-PLUS Hip Stem is indicated for uncemented use 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 (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. Smith & Nephew Orthopaedics AG SLR-PLUS Hip Stems are intended for single use only.
Prescription Use __ X_ (Part 21 CFR 801.109)
AND/OR
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qoutu for mxn
(Division Sign-Ord) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093991
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