510(k) · Cleared
ClearedDigimatch Robodoc Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Surgical Systems, Inc. · OJP Orthopedic Computer Controlled Surgical System
Cleared on Aug 6, 2008 as substantially equivalent to K052851 (Mako Surgical Corp., 2005) and 2 other predicates after a 324-day review. Its family tree reaches back 6 generations to 1994. 16 later devices descend from it.
- Decided
- Aug 6, 2008
- Review
- 324 days
- Class
- Class II
- Product code
- OJP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K930667 (1994). 35 ancestors in all, the oldest K811452 (1981). 16 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 5 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 4 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 3 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 2 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 1 generation backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- This deviceK072629 Digimatch Robodoc Surgical SystemIntegrated Surgical Systems, Inc. · 2008
- Descendant · cites it directly · 10 of its ownK140585 CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation · 2014
- Descendant · 2 generations on · 9 of its ownK150741 TSolution One w/ACG surgical SystemTHINK Surgical, Inc. · 2015
- Descendant · 3 generations on · 8 of its ownK153647 TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc. · 2016
- Descendant · 4 generations on · 7 of its ownK162195 TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. · 2016
- Descendant · 5 generations on · 6 of its ownK170430 TSolution One Surgical System Model 210THINK Surgical, Inc. · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K140585CTC Tcat (R)-Tplan (R) Surgical SystemCurexo Technology Corporation · 2014 · cites it directly10descendants
- K150741TSolution One w/ACG surgical SystemTHINK Surgical, Inc. · 2015 · 2 generations on9descendants
- K153647TSolution One w/ACG+ Surgical SystemTHINK Surgical, Inc. · 2016 · 3 generations on8descendants
- K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. · 2016 · 4 generations on7descendants
- K170430TSolution One Surgical System Model 210THINK Surgical, Inc. · 2017 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −5 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −4 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −3 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −2 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −1 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| 0 (this device) | K072629 | Digimatch Robodoc Surgical System | Integrated Surgical Systems, Inc. | 2008 | — |
| +1 | K140585 | CTC Tcat (R)-Tplan (R) Surgical System | Curexo Technology Corporation | 2014 | — |
| +2 | K150741 | TSolution One w/ACG surgical System | THINK Surgical, Inc. | 2015 | — |
| +3 | K153647 | TSolution One w/ACG+ Surgical System | THINK Surgical, Inc. | 2016 | — |
| +4 | K162195 | TSolution One Cup1 Surgical System | THINK Surgical, Inc. | 2016 | — |
| +5 | K170430 | TSolution One Surgical System Model 210 | THINK Surgical, Inc. | 2017 | — |
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 | 2 | 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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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 OJP? 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? (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 |
|---|---|---|---|
| * | K052851 | Voyager Linux with Tactile Guidance System (TGS)Summary page 1…21 CFR 882.4560 Substantial Equivalence Claim The DigiMatch TM ROBODOC® Surgical System is substantially equivalent. to the Voyager/Tactile Guidance System - CT (K05285 1), the Frameless Neuromate (K991081) and the da Vinci Surgical System (K043153). Device Description The DigiMatchTM ROBODOC® Sur… | 2005 |
| * | K991081 | Frameless NeuromateSummary page 1…quivalence Claim The DigiMatch TM ROBODOC® Surgical System is substantially equivalent. to the Voyager/Tactile Guidance System - CT (K05285 1), the Frameless Neuromate (K991081) and the da Vinci Surgical System (K043153). Device Description The DigiMatchTM ROBODOC® Surgical System consists of the 510(k)… | 1999 |
| * | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Summary page 1…Surgical System is substantially equivalent. to the Voyager/Tactile Guidance System - CT (K05285 1), the Frameless Neuromate (K991081) and the da Vinci Surgical System (K043153). Device Description The DigiMatchTM ROBODOC® Surgical System consists of the 510(k)-cleared (K960685) ORTHODOC® Preoperative P… | 2004 |
What descends from it? (16)
See all 163 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 14 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 35 ancestors have a recall of any class.
- Of its descendants, K140585 (Curexo Technology Corporation, 2014) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K052851.
How does its category compare?
All OJP devicesOJP Orthopedic Computer Controlled Surgical System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OJP
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · OJP
Too few OJP 510(k)s in any year since 2007 to give a median.
Recalls per year · OJP
No recall names OJP since 2007.
Adverse event reports per year · OJP
1in 2022
MAUDE reports naming product code OJP, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DigiMatchTM ROBODOC® Surgical System is intended for use as a device, which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan. The preoperative planning software and robotic surgical tool is…
Read the full statement (121 words)
The DigiMatchTM ROBODOC® Surgical System is intended for use as a device, which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
The DigiMatch ROBODOC Surgical System is indicated for Orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072629: Digimatch Robodoc Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072629
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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