510(k) · Cleared
ClearedThe Artas System From Restoration Robotics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Restoration Robotics, Inc. · ONA Computer Assisted Hair Harvesting System
Cleared on Apr 4, 2011 as substantially equivalent to K952737 (Medicamat S.A., 1995) and 1 other predicate after a 133-day review. Its family tree reaches back 7 generations to 1994. 3 later devices descend from it.
- Decided
- Apr 4, 2011
- Review
- 133 days
- Class
- Class II
- Product code
- ONA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K930667 (1994). 37 ancestors in all, the oldest K811452 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 6 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 5 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 4 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 3 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 2 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 1 generation backK072629 Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc. · 2008
- This deviceK103428 The Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK123548 The Artas SystemRestoration Robotics, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK173358 ARTAS SystemRestoration Robotics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK123154 Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −6 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −5 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −4 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −3 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −2 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −1 | K072629 | Digimatch Robodoc Surgical System | Integrated Surgical Systems, Inc. | 2008 | — |
| 0 (this device) | K103428 | The Artas System From Restoration Robotics | Restoration Robotics, Inc. | 2011 | — |
| +1 | K123548 | The Artas System | Restoration Robotics, Inc. | 2013 | 4 |
| +2 | K173358 | ARTAS System | Restoration Robotics, Inc. | 2018 | — |
| +1 | K123154 | Artas System From Restoration Robotics | Restoration Robotics, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2018 | 1 | 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 ONA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K952737 | Calvitron Hair Transplant SystemSummary page 1…xic Instrument PREDICATE DEVICES The ARTAS System is substantially equivalent to the following predicate devices: * Medicamnat S.A. Calvitron Hair Transplant System, K952737 " Integrated Surgical Systems, Inc. DigiMatch ROBODOC Surgical System, K072629 RESTORATION ROBOTICS, INC.… | 1995 |
| * | K072629 | Digimatch Robodoc Surgical SystemSummary page 1…ollowing predicate devices: * Medicamnat S.A. Calvitron Hair Transplant System, K952737 " Integrated Surgical Systems, Inc. DigiMatch ROBODOC Surgical System, K072629 RESTORATION ROBOTICS, INC. THE ARTAS h SYSTEM FROM RESTORATION ROBOTICS… | 2008 |
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)
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 17 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 37 ancestors have a recall of any class.
- Of its descendants, K123548 (Restoration Robotics, Inc., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All ONA devicesONA Computer Assisted Hair Harvesting System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ONA
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · ONA
Too few ONA 510(k)s in any year since 2007 to give a median.
Recalls per year · ONA
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONA
1in 2015
MAUDE reports naming product code ONA, 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 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 4 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARTAS System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103428: The Artas System From Restoration Robotics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103428
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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