510(k) · Cleared
Recalled · Class II · 2016Mets Smiles Total Knee Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stanmore Implants Worldwide, Ltd. · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Cleared on Sep 5, 2012 as substantially equivalent to K092138 (Stanmore Implants Worldwide, Ltd., 2011) and 2 other predicates after a 156-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 5, 2012
- Review
- 156 days
- Class
- Class II
- Product code
- KRO
- Recalls
- 6
- Predicates
- 3
Its longest line of descent runs back 2 generations to K945028 (1996). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945028 Finn Knee SystemBiomet, Inc. · 1996
- 1 generation backK051570 Avl Hinge Knee SystemBiomet, Inc. · 2005
- This deviceK120992 Mets Smiles Total Knee ReplacementStanmore Implants Worldwide, Ltd. · 2012
- Descendant · cites it directly · 2 of its ownK133152 JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK140900 Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK140898 Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd. · 2015 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K133152JTS Extendible Distal Femoral ImplantStanmore Implants Worldwide, Ltd. · 2014 · cites it directly2descendants
- K140900Patient Specific Smiles Total Knee ReplacementStanmore Worldwide Implants, Ltd. · 2015 · cites it directly0descendants
- K140898Patient Specific Distal FemoralStanmore Implants Worldwide, Ltd. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945028 | Finn Knee System | Biomet, Inc. | 1996 | — |
| −1 | K051570 | Avl Hinge Knee System | Biomet, Inc. | 2005 | — |
| 0 (this device) | K120992 | Mets Smiles Total Knee Replacement | Stanmore Implants Worldwide, Ltd. | 2012 | — |
| +1 | K133152 | JTS Extendible Distal Femoral Implant | Stanmore Implants Worldwide, Ltd. | 2014 | 1 |
| +1 | K140900 | Patient Specific Smiles Total Knee Replacement | Stanmore Worldwide Implants, Ltd. | 2015 | — |
| +2 | K140898 | Patient Specific Distal Femoral | Stanmore Implants Worldwide, Ltd. | 2015 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K092138 | JTS Extendeable ImplantSummary page 1…licyassociates.com Tel: (781) 329-2993 Fax: (781) 329-2958 Equivalent to ITS Extendible Implant, Stanimore Implants (K09213 8), AVL Hinge Knee Biomet (K(051570) and the Repiphysis Limb Salvage System Wright Medi… | 2011 |
| * | K051570 | Avl Hinge Knee SystemSummary page 1…93 Fax: (781) 329-2958 Equivalent to ITS Extendible Implant, Stanimore Implants (K09213 8), AVL Hinge Knee Biomet (K(051570) and the Repiphysis Limb Salvage System Wright Medical (K02 1489) The single use MET… | 2005 |
| * | K021489 | Repiphysis Limb Salvage SystemSummary page 1…plant, Stanimore Implants (K09213 8), AVL Hinge Knee Biomet (K(051570) and the Repiphysis Limb Salvage System Wright Medical (K02 1489) The single use METS® Smiles Total Knee Replacement is Device Description intended for the replacement… | 2002 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2016 | Class II | Z-0823-2017 | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. |
| Dec 7, 2016 | Class II | Z-0820-2017 | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. |
| Dec 7, 2016 | Class II | Z-0821-2017 | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. |
| Dec 7, 2016 | Class II | Z-0822-2017 | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. |
| Dec 7, 2016 | Class II | Z-0824-2017 | Packaging | The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem. |
| May 31, 2016 | Class II | Z-2553-2016 | Device Design | The manufacturer has identified that the stated Femoral Plateau Plates may not fit into the intended Femoral Knee mating component and thus sit flush upon the Femoral Knee component prior to implantation. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K133152 (Stanmore Implants Worldwide, Ltd., 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K092138.
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. 2012, 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 METS® Smiles Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. 1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis 2. Correction of varus, valgus or post traumatic deformity 3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 4. Ligament deficiencies 5. Tumor resections 6.…
Read the full statement (117 words)
The METS® Smiles Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint.
1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
2. Correction of varus, valgus or post traumatic deformity
3. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
4. Ligament deficiencies
5. Tumor resections
6. Revision of previously failed total joint arthroplasty
7. Trauma
8. The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue
The METS® Smiles Total Knee Replacement is for cemented use only.
The METS® Smiles Total Knee Replacement and its components are for single use only
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120992: Mets 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/K120992
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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