510(k) · Cleared
Recalled · Class II · 2013The Artas System
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 Feb 25, 2013 as substantially equivalent to K103428 (Restoration Robotics, Inc., 2011) after a 98-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Feb 25, 2013
- Review
- 98 days
- Class
- Class II
- Product code
- ONA
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 8 generations to K930667 (1994). 38 ancestors in all, the oldest K811452 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 7 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 6 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 5 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 4 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 3 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 2 generations backK072629 Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc. · 2008
- 1 generation backK103428 The Artas System From Restoration RoboticsRestoration Robotics, Inc. · 2011
- This deviceK123548 The Artas SystemRestoration Robotics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK173358 ARTAS SystemRestoration Robotics, Inc. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173358ARTAS SystemRestoration Robotics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −7 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −6 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −5 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −4 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −3 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −2 | K072629 | Digimatch Robodoc Surgical System | Integrated Surgical Systems, Inc. | 2008 | — |
| −1 | K103428 | The Artas System From Restoration Robotics | Restoration Robotics, Inc. | 2011 | — |
| 0 (this device) | K123548 | The Artas System | Restoration Robotics, Inc. | 2013 | — |
| +1 | K173358 | ARTAS System | Restoration Robotics, Inc. | 2018 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K103428 | The Artas System From Restoration RoboticsSummary page 2…ATION ROBOT ICS 510(k) SUMMARY PREDICATE DEVICE(S) The proposed ARTASTM System is substantially equivalent to the following predicate devices: * ARTASTM System, K103428 " Recipient Site Blades (Manual Surgical Instruments, Regulation No. 878.4800, Class 1, exempt) INTENDED USE The… | 2011 |
| * | — | Recipient Site Blades Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173358 | ARTAS System | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2013 | Class II | Z-0356-2014 | Process control | Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified… |
| Oct 13, 2013 | Class II | Z-0354-2014 | Process control | Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified… |
| Oct 13, 2013 | Class II | Z-0353-2014 | Process control | Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified… |
| Oct 13, 2013 | Class II | Z-0355-2014 | Process control | Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K173358 (Restoration Robotics, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K103428.
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. 2013, 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. The ARTAS System is also indicated for creating recipient sites for subsequent manual implantation of the harvested follicles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123548 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123548: The Artas System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123548
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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