(96 days)
Not Found
No
The summary describes a mechanical hip implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total hip component, specifically a modular hip stem and sleeves, indicated for use in primary and revision hip surgery to rehabilitate hips damaged by various conditions like trauma, inflammatory joint disease, or noninflammatory degenerative joint disease. This aims to restore function and alleviate symptoms.
No
Explanation: The device is described as a "Total hip component" which is an implant for surgical replacement of hip joints. Its intended use is for individuals undergoing primary and revision surgery involving damaged hips, not for diagnosing conditions.
No
The device description clearly states it consists of physical components (stems, sleeves, heads, acetabular components) made from materials like Ti-6Al-4V, indicating it is a hardware medical device, not software-only.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a total hip replacement system consisting of stems, sleeves, and other components. Its intended use is for surgical implantation to replace damaged hip joints.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or perform any kind of diagnostic test. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, this device is a surgical implant and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Total hip components are 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 Modular Hip components are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
MEH
Device Description
The Smith & Nephew Modular Hip consists of primary and revision stems used with porous and HA coated modular sleeves. The stems feature a 12/14 taper and are used with existing Smith & Nephew femoral heads and acetabular components. Modular hip stems and sleeves are manufactured from Ti-6Al-4V conforming to ASTM F 1472 or ASTM F 136.
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)
A review of the mechanical test data indicated that the Smith & Nephew Modular Hip is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
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.
K92111, K934412, K954935, K961939, K963509, K991485, K002996, K042127
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
i - l
Smith & Nephew, Inc. Summary of Safety and Effectiveness Smith & Nephew Modular Hip Line Additions
KOS2426 pYi
Contact Person and Address
Bate of Summary: September 1, 2005
Jason Sells Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, TN 38116 (901) 399-5520
Name of Device: Smith & Nephew Modular Hip Common Name: Prosthetic hip joint
Device Description
The Smith & Nephew Modular Hip consists of primary and revision stems used with porous and HA coated modular sleeves. The stems feature a 12/14 taper and are used with existing Smith & Nephew femoral heads and acetabular components. Modular hip stems and sleeves are manufactured from Ti-6Al-4V conforming to ASTM F 1472 or ASTM F 136.
Device Classification
21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II
Mechanical and Clinical Data
A review of the mechanical test data indicated that the Smith & Nephew Modular Hip is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure.
Indications for Use
Total hip components are 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 Modular Hip components are for single use only.
Substantial Equivalence Information
The substantial equivalence of the Smith & Nephew Modular Hip is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate devices - Joint Medical Products S-ROM Total Hip System (K92111), K934412, K954935, and K961939), the Smith & Nephew Synergy Hip System (K963509, K991485, and K002996), and the Smith & Nephew Modular Hip System (K042127). The subject devices are line addition components to the Smith & Nephew Modular Hip System cleared via K042127,
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Standards Data Form for Abbreviated 510(k)s
510(k) Number: K052126
:
Standard Organization No:
or
Standard Identification No: ISO 7206-4 (1989)
ASTM F67
ASTM F1472, ASTM
ASTM F 136
or
CDRH Internal Reference No:
| Declaration of Conformity Elements: | |
|---|---|
| Any Adaptations Applied | yes no |
| Any Requirements Not Applicable | yes no |
| Any Deviations Applied | yes no |
| Any Differences in Device Tested and Finished Product | yes no |
| *Is There a Third Party or Test Lab Involved | yes no |
Was there another standard used in the review of this submission? yes no
If another standard was used, please fill out an additional form.
- This is not the third party that reviews 510ks
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The logo also includes the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES · USA" arranged in a circular pattern around the caduceus symbol.
DEC 7 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Jason Sells Regulatory Affairs Specialist Smith &Nephew, Inc Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K052426
Trade/Device Name: Smith & Nephew Modular Hip 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: MEH Dated: November 29, 2005 Received: November 30, 2005
Dear Mr. Sells:
We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your bochen 9 re(s) personalially equivalent (for the indications ferenced above and nave determing ally marketed predicate devices marketed in interstate for use statuu in the encrobare) to 10gaily to 10gails and the Medical Device Amendments, or to commerce pror to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been receissmed in assessment of a premarket approval application (PMA). alle Cosmetic Act (Act) that to not requent of the general controls provisions of the Act. The r ou may, mercedore, manot the Act include requirements for annual registration, listing of general controls provisions of the rice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class II (PMA), in II your device is classified (600 a0070) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA Inay be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Ood of reants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that i Dri 3 issuance or our device complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must of any I cochar statutes and regulations and limited to: registration and listing (21 Compry with an the Her S requirements, 01); good manufacturing practice requirements as set CIN in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quality by bloms (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Jason Sells
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin marketing your and equivalence of your device to a legally premarket notification. The PDA maing of basification 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 If you desire specific advice for your act (240) 276-0120. Also, please mote the regulation entitled, and "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misbranding by reference to premaintential international the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet andress http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
signature
San Mark N. Melkerson
Acting Director Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KOS 2476 510(k) Number (if known):
Device Name: Smith & Nephew Modular Hip
Indications for Use:
Total hip components are indicated for uncemented use in individuals undergoing primary and rolar mp components are fire treatments or devices have failed in rehabilitating hips damaged as renout of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJ) or any of its composite diagnoses such as osteoarthritis; degenerality for it and arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; avascalar noeroant; old, remote osteomyelitis with an extended drainage-free period; nonunion, andor pril fracture and trochanteric fractures of the proximal femur with head involvement that remoral receit industans and the techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Modular Hip components are for single use only.
メ Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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