510(k) Report

510(k) · Cleared

Cleared

Ignite Anatomic Shoulder System

K202716510(k) TraditionalCleared May 20, 2021245-day reviewClass II21 CFR 888.3670

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ignite Orthopedics, LLC · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on May 20, 2021 as substantially equivalent to K060692 (Biomet Manufacturing Corp, 2006) and 9 other predicates after a 245-day review. Its family tree reaches back 14 generations to 1991. 1 of the 173 devices in its family, counting itself, has a Class I recall. 13 later devices descend from it.

Decided
May 20, 2021
Review
245 days
Class
Class II
Product code
MBF
Recalls
None
Predicates
10

Its longest line of descent runs back 14 generations to K911686 (1991). 159 ancestors in all, the oldest K790987 (1979). 13 later devices descend from it, 5 citing it directly. 1 of the 173 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2016: 1 other ancestor2012: 5 other ancestors2011: 7 other ancestors2009: 3 other ancestors2006: 11 other ancestors2005: 9 other ancestors1991: 2 other ancestors2014: 1 other ancestor2013: 2 other ancestors2008: 7 other ancestors2007: 7 other ancestors2004: 8 other ancestors2003: 9 other ancestors2002: 4 other ancestors2000: 7 other ancestors1999: 5 other ancestors1998: 7 other ancestors1997: 3 other ancestors2010: 3 other ancestors2001: 7 other ancestors1996: 6 other ancestors1995: 7 other ancestors1994: 4 other ancestors1993: 3 other ancestors1992: 5 other ancestors1989: 1 other ancestor1988: 1 other ancestor1987: 5 other ancestors1986: 1 other ancestor1979: 1 other ancestor1980: 2 other ancestors1981: 1 other ancestor2023: 1 descendant cleared2022: 4 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 5 descendants cleared2025: 1 descendant clearedK911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991×2: 2 generations cleared close together, K984541 (1999), K992065 (1999) ×3: 3 generations cleared close together, K021478 (2003), K030941 (2004), K041873 (2004) ×2: 2 generations cleared close together, K052906 (2005), K060704 (2006) K063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalled×2: 2 generations cleared close together, K073688 (2008), K080642 (2008) ×2: 2 generations cleared close together, K110599 (2011), K112615 (2011) K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 21 other ancestors3 generations back: 38 other ancestors4 generations back: 25 other ancestors5 generations back: 29 other ancestors6 generations back: 9 other ancestors7 generations back: 3 other ancestors8 generations back: 8 other ancestors9 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 2 descendants K122698 · Aequalis Ascend Flex Shoulder System · Tornier S.A.S. · 2013 · recalledK112615 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K110599 · Aequalis Ascend Modular Reverse Shoulder System · Tornier, Inc. · 2011K080642 · Comprehensive Reverse Shoulder · Biomet, Inc. · 2008 · Class I recallK073688 · Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw · Exactech, Inc. · 2008 · recalledK063569 · Equinoxe Reverse Shoulder System · Exactech, Inc. · 2007 · recalledK060704 · Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM · Zimmer, Inc. · 2006 · recalledK052906 · Zimmer Trabecular Metal Reverse Shoulder System · Zimmer, Inc. · 2005 · recalledK041873 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K030941 · Aequalis Reversed Shoulder Prosthesis · Tornier · 2004K021478 · Delta Shoulder · Depuy, Inc. · 2003K992065 · Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head · DePuy Orthopaedics, Inc. · 1999K984541 · Global FX Humeral Stem, Global Advantage Humeral Head · DePuy Orthopaedics, Inc. · 1999K911686 · Global Total Shoulder, Uncement Humeral Hemi-Shoul · Depuy, Inc. · 1991−10−50
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 10 generations between
  3. 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  4. 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  5. 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  6. This deviceK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
  7. Descendant · cites it directly · 9 of its ownK212737 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
  8. Descendant · cites it directly · 3 of its ownK203108 Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021
  9. Descendant · 2 generations on · 1 of its ownK250644 MSS - Monobloc stemMedacta International S.A. · 2026 · Recalled
  10. Descendant · 2 generations on · 1 of its ownK241817 InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025
  11. Descendant · cites it directly · 1 of its ownK212933 INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC · 2022
Show all 14 generations
  1. Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
  5. 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  6. 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
  7. 8 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
  8. 7 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
  9. 6 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  10. 5 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
  11. 4 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  12. 3 generations backK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  13. 2 generations backK112615 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
  14. 1 generation backK122698 Aequalis Ascend Flex Shoulder SystemTornier S.A.S. · 2013 · Recalled
  15. This deviceK202716 Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2021: 12022: 42023: 12024: 12025: 12026: 5
2021high 5 (2026) · low 1 (2021)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder2 generations back · 2008

Most influential descendants

Showing 5 of 13 · See all
  • K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022 · cites it directly9descendants
  • K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021 · cites it directly3descendants
  • K250644MSS - Monobloc stemMedacta International S.A. · 2026 · 2 generations on1descendant
  • K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025 · 2 generations on1descendant
  • K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC · 2022 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
−13K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
−12K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
−11K021478Delta ShoulderDepuy, Inc.2003—
−10K030941Aequalis Reversed Shoulder ProsthesisTornier2004—
−9K041873Aequalis Reversed Shoulder ProsthesisTornier2004—
−8K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200512
−7K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200610
−6K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
−5K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081
−4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
−3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011—
−1K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.20132
0 (this device)K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC2021—
+1K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC2022—
+1K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC2021—
+2K250644MSS - Monobloc stemMedacta International S.A.20261
+2K241817InSet Total Shoulder SystemShoulder Innovations, Inc.2025—
+1K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198020
198110
198610
198750
198810
198910
199120
199250
199330
199440
199570
199660
199730
199870
199950
200070
200170
200240
200390
200480
200590
2006110
200770
200870
200930
201030
201170
201250
201320
201410
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202240
202310
202410
202510
202650
FIG. 1 — Lineage of K202716, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

1 device in this family has a Class I recall. 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 MBF device

  1. #1 K220792 SMR Reverse Linerscore 17.2 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K060692Comprehensive Primary Shoulder Stems
Summary page 4
…Uncemented (21 CER §888.3690); Class II Product Codes: MBF, KWT, KWS, PAO, HSD Substantially Equivalent Predicate Devices: K060692 (Primary) - Comprehensive Primary Shoulder Stems, Biomet Manufacturing Corp.…
Biomet Manufacturing Corp20066
*K060694Modular Hybrid Glenoid
Summary page 5
…Manufacturing Corp. K202716-Page 2 of 3 K060694 - Modular Hybrid Glenoid, Biomet Manufacturing Corp. K060716 - Versa-Dial Humeral Head Prosthesis, Biome…
Biomet Manufacturing Corp20064
*K060716Versa-Dial Humeral Head Prosthesis
Summary page 5
…K202716-Page 2 of 3 K060694 - Modular Hybrid Glenoid, Biomet Manufacturing Corp. K060716 - Versa-Dial Humeral Head Prosthesis, Biomet Manufacturing Corp. K162024 - Alti…
Biomet Manufacturing Corp2006—
*K162024AltiVate Anatomic Shoulder System
Summary page 5
…t Manufacturing Corp. K060716 - Versa-Dial Humeral Head Prosthesis, Biomet Manufacturing Corp. K162024 - Altivate Anatomic Shoulder System, Encore Medical, L.P. K111596 - Total Shoulder System, Shoulder Inno…
Encore Medical L.P.20166
*K111596Total Shoulder System
Summary page 5
…, Biomet Manufacturing Corp. K162024 - Altivate Anatomic Shoulder System, Encore Medical, L.P. K111596 - Total Shoulder System, Shoulder Innovations, LLC K091196 - Arthrosurface GRS™ Glenoid Resurfacing Syst…
Shoulder Innovations, LLC2011—
*K091196GRS Glenoid Resurfacing System
Summary page 5
…24 - Altivate Anatomic Shoulder System, Encore Medical, L.P. K111596 - Total Shoulder System, Shoulder Innovations, LLC K091196 - Arthrosurface GRS™ Glenoid Resurfacing System, Arthrosurface, Inc. K122698 -…
Arthrosurface, Inc.2009—
*K122698Aequalis Ascend Flex Shoulder System
Summary page 5
…Innovations, LLC K091196 - Arthrosurface GRS™ Glenoid Resurfacing System, Arthrosurface, Inc. K122698 - Aequalis Ascend Flex Shoulder System, Tornier SAS K905786 – Global Total Shoulder, DePuy Inc.…
Tornier S.A.S.20132
*K905786Global Total Shoulder
Summary page 5
…facing System, Arthrosurface, Inc. K122698 - Aequalis Ascend Flex Shoulder System, Tornier SAS K905786 – Global Total Shoulder, DePuy Inc. K052472 – DePuy Global Shoulder Crosslink Glenoid, DePuy…
Depuy, Inc.1991—
*K052472Depuy Global Shoulder Crosslink Glenoid
Summary page 5
…K122698 - Aequalis Ascend Flex Shoulder System, Tornier SAS K905786 – Global Total Shoulder, DePuy Inc. K052472 – DePuy Global Shoulder Crosslink Glenoid, DePuy Orthopedics, Inc. K121183 – Co…
DePuy Orthopaedics, Inc.2005—
*K121183Comprehensive Reverse Shoulder - E1 Polyethylene Claims
Summary page 5
…houlder, DePuy Inc. K052472 – DePuy Global Shoulder Crosslink Glenoid, DePuy Orthopedics, Inc. K121183 – Comprehensive Reverse Shoulder – E1 Polyethylene Claims, Biomet Manufacturing Device Description: Th…
Biomet Corporation2012—

Also cleared against K060692: 14 other devices →

What descends from it? (13)

See all 13

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229
K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213
K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221
K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230
K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
  • 46 of the 159 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K212737 (Depuy Ireland UC, 2022) has gone furthest, with 9 descendants of its own.
  • 14 other devices also cite its predicate K060692.

How does its category compare?

All MBF devices

MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · MBF

2in 2025

2007: 22008: 12009: 12012: 22013: 12014: 12017: 22018: 12019: 22020: 22021: 12022: 42023: 42024: 22025: 22026 (partial year): 1
2007high 4 (2022) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBF

144in 2023

2022: 164 days median2023: 144 days median
2007high 164 (2022) · low 144 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBF

1in 2023

2009: 12017: 12018: 12019: 22022: 82023: 1
2007high 8 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MBF

255in 2025

2007: 22008: 72009: 162010: 242011: 322012: 302013: 402014: 282015: 492016: 852017: 1932018: 992019: 472020: 242021: 362022: 1142023: 1432024: 1642025: 255
2007high 255 (2025) · low 2 (2007)2025

MAUDE reports naming product code MBF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—02
20081—07
20091—116
20100—024
20110—032
20122—030
20131—040
20141—028
20150—049
20160—085
20172—1193
20181—199
20192—247
20202—024
20211—036
202241648114
202341441143
20242—0164
20252—0255
20261—0—

What is it indicated for?

The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures to address the following:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

» Rheumatoid arthritis.

* Revision where other devices or treatments have failed.

* Correction of functional deformity.

* Fracture of the humeral head

» Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods

The humeral stem is intended for cemented or cementless use. The glenoid is intended for cemented use only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K060692

14 other devices cite the same predicate.

  • K241817InSet Total Shoulder SystemShoulder Innovations, Inc. · 2025
  • K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2022
  • K202024ARROW Short Stem Humeral SystemFH Industrie · 2021
  • K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG · 2021
  • K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp · 20201 recall
  • K191963SMR Finned Short StemsLima Corporate S.P.A. · 2019

More from Ignite Orthopedics, LLC

2 FDA decisions under this applicant name. See the company

  • K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC · 2021

Recent decisions in MBF

The MBF category page

  • K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive…Zimmer, Inc. · 2026
  • K251098Identity Revision Humeral StemsZimmer, Inc. · 2025
  • K250848Identity Shoulder SystemZimmer, Inc. · 2025
  • K240876Identity Shoulder SystemZimmer, Inc. · 2024
  • K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A. · 2024

https://510kreport.com/device/K202716 · printed Nov 6, 2026

Cite this page

510(k) Report. “K202716: Ignite Anatomic Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202716

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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