510(k) · Cleared
ClearedPatient Specific Smiles Total Knee Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stanmore Worldwide Implants, Ltd. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Feb 12, 2015 as substantially equivalent to K120992 (Stanmore Implants Worldwide, Ltd., 2012) and 2 other predicates after a 310-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Feb 12, 2015
- Review
- 310 days
- Class
- Class II
- Product code
- KRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945028 (1996). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 3 generations backK051570 Avl Hinge Knee SystemBiomet, Inc. · 2005
- 2 generations backK120992 Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd. · 2012 · Recalled
- 1 generation backK133152 JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · Recalled
- This deviceK140900 Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −3 | K051570 | Avl Hinge Knee System | Biomet, Inc. | 2005 | — |
| −2 | K120992 | Mets Smiles Total Knee Replacement | Stanmore Implants Worldwide, Ltd. | 2012 | 6 |
| −1 | K133152 | JTS Extendible Distal Femoral Implant | Stanmore Implants Worldwide, Ltd. | 2014 | 1 |
| 0 (this device) | K140900 | Patient Specific Smiles Total Knee Replacement | Stanmore Worldwide Implants, Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KRO device
- #1 K251665 Triathlon® Hinge Knee Systemscore 19.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120992 | Mets Smiles Total Knee ReplacementSummary page 6…ement and its components are for cemented use only. Predicate Device(s) The predicate devices are the METS® SMILES Total Knee Replacement cleared on September 5,2012 (K120992), the ITS® Extendible Distal Femoral Implant cleared on March 22, 2011(K092138) and the JTS® Extendible Distal Femoral Implant cl… | 2012 |
| * | K092138 | JTS Extendeable ImplantSummary page 6…predicate devices are the METS® SMILES Total Knee Replacement cleared on September 5,2012 (K120992), the ITS® Extendible Distal Femoral Implant cleared on March 22, 2011(K092138) and the JTS® Extendible Distal Femoral Implant cleared on January 22, 2014 (K133152). Technological Characteristics The Patient… | 2011 |
| * | K133152 | JTS Extendible Distal Femoral ImplantSummary page 6…2012 (K120992), the ITS® Extendible Distal Femoral Implant cleared on March 22, 2011(K092138) and the JTS® Extendible Distal Femoral Implant cleared on January 22, 2014 (K133152). Technological Characteristics The Patient Specific SMILES Total Knee Replacement is a patient-specific implant system that is… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 6 of the 12 ancestors have a recall of any class.
- 1 other device also cites its predicate K120992.
How does its category compare?
All KRO devicesKRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KRO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRO
56in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRO
14so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRO
915in 2025
MAUDE reports naming product code KRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 37 |
| 2008 | 3 | 126 | 3 | 44 |
| 2009 | 3 | 86 | 8 | 66 |
| 2010 | 1 | — | 0 | 110 |
| 2011 | 2 | — | 1 | 119 |
| 2012 | 2 | — | 1 | 173 |
| 2013 | 3 | 189 | 2 | 194 |
| 2014 | 2 | — | 0 | 406 |
| 2015 | 6 | 113 | 1 | 333 |
| 2016 | 3 | 148 | 5 | 369 |
| 2017 | 1 | — | 4 | 543 |
| 2018 | 0 | — | 1 | 614 |
| 2019 | 3 | 244 | 0 | 759 |
| 2020 | 1 | — | 0 | 749 |
| 2021 | 3 | 57 | 1 | 770 |
| 2022 | 1 | — | 0 | 892 |
| 2023 | 4 | 148 | 0 | 746 |
| 2024 | 3 | 87 | 0 | 855 |
| 2025 | 3 | 56 | 1 | 915 |
| 2026 | 1 | — | 14 | — |
What is it indicated for?
The Patient Specific SMILES Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. It is indicated for: Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis Correction of varus, valgus or post traumatic deformity Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement Ligament deficiencies Tumor…
Read the full statement (121 words)
The Patient Specific SMILES Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. It is indicated for:
Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resection
Revision of previously failed total joint arthroplasty
Trauma
The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue
The Patient Specific SMILES Total Knee Replacement and its components are for cemented use only.
The Patient Specific Patient Specific SMILES Total Knee Replacement and its components are for single use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140900: Patient Specific Smiles Total Knee Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140900
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026