510(k) · Cleared
ClearedRestoris Porous Partial Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mako Surgical Corp. · NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Cleared on Jul 8, 2014 as substantially equivalent to K090763 (Mako Surgical Corporation, 2009) and 2 other predicates after a 204-day review. Its family tree reaches back 7 generations to 1994. 19 later devices descend from it.
- Decided
- Jul 8, 2014
- Review
- 204 days
- Class
- Class II
- Product code
- NJD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K943462 (1994). 38 ancestors in all, the oldest K880155 (1988). 19 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 6 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 5 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 4 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 3 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 2 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 1 generation backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- This deviceK133811 Restoris Porous Partial Knee SystemMako Surgical Corp. · 2014
- Descendant · cites it directly · 8 of its ownK163700 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017
- Descendant · 2 generations on · 7 of its ownK181302 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · cites it directly · 5 of its ownK190439 Engage™ Partial Knee SystemEngage Uni, LLC · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK191150 Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK230653 Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee…Smith & Nephew, Inc. · 2023 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K163700Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2017 · cites it directly8descendants
- K181302Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · 2 generations on7descendants
- K190439Engage™ Partial Knee SystemEngage Uni, LLC · 2019 · cites it directly5descendants
- K191150Bodycad Unicompartmental Knee SystemBodycad Laboratories, Inc. · 2019 · 2 generations on4descendants
- K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc. · 2023 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −6 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −5 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −4 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −3 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −2 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −1 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| 0 (this device) | K133811 | Restoris Porous Partial Knee System | Mako Surgical Corp. | 2014 | — |
| +1 | K163700 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2017 | — |
| +2 | K181302 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +1 | K190439 | Engage™ Partial Knee System | Engage Uni, LLC | 2019 | 4 |
| +2 | K191150 | Bodycad Unicompartmental Knee System | Bodycad Laboratories, Inc. | 2019 | — |
| +2 | K230653 | Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System… | Smith & Nephew, Inc. | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 NJD? 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 NJD device
- #1 K242307 ACHIEVE Partial Knee Systemscore 13.6 · 8 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 |
|---|---|---|---|
| * | K090763 | Restoris Multicompartmental Knee (MCK) SystemSummary page 1…plate components are compatible and are intended for use with predicate MAKO Restoris MCK Tibial Onlay Inserts in standard UHMWPE or highly crosslinked vitamin E UHMWPE (K090763, K133039). The sagittal articular surface of the femoral condyle has an extended posterior radius that accommodates flexion up to… | 2009 |
| * | K082172 | Mako Modular Knee Compartmental Implant SystemSummary page 2…Date Restoris MCK Knee System MAKO Surgical K090763 6/17/2009 MMCK Uni Knee System MAKO Surgical K082172 11/28/2008 Natural-Knee® 11Unicompartmental CenterPulse Knee System Orthopedics/Zimm… | 2008 |
| * | K033810 | Natural-Knee II Unicompartmental Knee SystemSummary page 2…MAKO Surgical K082172 11/28/2008 Natural-Knee® 11Unicompartmental CenterPulse Knee System Orthopedics/Zimmer K033810 3/5/2004 MAKO Restoris® Hip System Orthopedics acquired K112802 0/221 (Pipeline Total Hip System)… | 2004 |
| † | K112802 | Pipeline Total Hip System | 2012 |
| † | K133039 | Restoris Multicompartmental Knee System | 2013 |
What descends from it? (19)
See all 195 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)
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 20 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 20 of the 38 ancestors have a recall of any class.
- Of its descendants, K163700 (Bodycad Laboratories, Inc., 2017) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K090763.
How does its category compare?
All NJD devicesNJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NJD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NJD
Too few NJD 510(k)s in any year since 2007 to give a median.
Recalls per year · NJD
No recall names NJD since 2007.
Adverse event reports per year · NJD
4in 2025
MAUDE reports naming product code NJD, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 34 |
| 2023 | 0 | — | 0 | 61 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions: * Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis. * Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis. * As an alternative to tibial osteotomy in patients…
Read the full statement (117 words)
The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:
* Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
* Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
* As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
The Restoris® Porous Femoral Component and PSTO Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133811: Restoris Porous Partial Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133811
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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