510(k) · Cleared
ClearedRingloc Constrained Liners II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Cleared on Oct 25, 2002 as substantially equivalent to P960054 (Depuy, A Johnson & Johnson Co., 1997) and 1 other predicate after a 154-day review. Its family tree reaches back 1 generation to 1997. 184 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 154 days
- Class
- Class II
- Product code
- KWZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P960047 (1997). 2 ancestors in all. 184 later devices descend from it, 2 citing it directly.
- Root · 1 generation backP960047 Osteonics Constrained Acetabular InsertHowmedica Osteonics Corp. · 1997
- This deviceK021728 Ringloc Constrained Liners IIBiomet, Inc. · 2002
- Descendant · cites it directly · 181 of its ownK030047 Freedom Constrained LinersBiomet, Inc. · 2003
- Descendant · 2 generations on · 160 of its ownK043537 Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005
- Descendant · 2 generations on · 53 of its ownK121874 G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · Recalled
- Descendant · 3 generations on · 35 of its ownK140669 G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014
- Descendant · 3 generations on · 33 of its ownK102399 Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010
Showing 5 of 184 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 184 · See all- K030047Freedom Constrained LinersBiomet, Inc. · 2003 · cites it directly181descendants
- K043537Taperloc 12/14 Taper Femoral ComponentsBiomet, Inc. · 2005 · 2 generations on160descendants
- K121874G7 Acetabular SystemBiomet Manufacturing Corp · 2012 · 2 generations on53descendants
- K140669G7 Osseoti Acetublar ShellsBiomet, Inc. · 2014 · 3 generations on35descendants
- K102399Consensus Taperset Hip SystemConsensus Orthopedics, Inc. · 2010 · 3 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P960047 | Osteonics Constrained Acetabular Insert | Howmedica Osteonics Corp. | 1997 | — |
| 0 (this device) | K021728 | Ringloc Constrained Liners II | Biomet, Inc. | 2002 | — |
| +1 | K030047 | Freedom Constrained Liners | Biomet, Inc. | 2003 | — |
| +2 | K043537 | Taperloc 12/14 Taper Femoral Components | Biomet, Inc. | 2005 | — |
| +2 | K121874 | G7 Acetabular System | Biomet Manufacturing Corp | 2012 | 3 |
| +3 | K140669 | G7 Osseoti Acetublar Shells | Biomet, Inc. | 2014 | — |
| +3 | K102399 | Consensus Taperset Hip System | Consensus Orthopedics, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 12 | 0 |
| 2013 | 6 | 0 |
| 2014 | 13 | 0 |
| 2015 | 9 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 6 | 0 |
| 2019 | 18 | 0 |
| 2020 | 8 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 9 | 0 |
| 2024 | 15 | 0 |
| 2025 | 17 | 0 |
| 2026 | 19 | 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 KWZ? 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 KWZ device
- #1 K241461 Mpact Constrained Linerscore 15.5 · 10 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | P960054 | S-Rom Poly-Dial Constrained LinerSummary page 1…3 10). Device Classification: Class I1 Legally Marketed Device to which Substantially Equivalence is Claimed: Johnson & Johnson S-ROMB Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047. Device Description: The RinglocB Constrained Acetabular Liners I1 are… | 1997 |
| * | P960047 | Osteonics Constrained Acetabular InsertSummary page 1…Device to which Substantially Equivalence is Claimed: Johnson & Johnson S-ROMB Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047. Device Description: The RinglocB Constrained Acetabular Liners I1 are polyethylene liners with a 10" beveled inner edge that, w… | 1997 |
What descends from it? (184)
See all 1842 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?
How does its category compare?
All KWZ devicesKWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWZ
104in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWZ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWZ
193in 2025
MAUDE reports naming product code KWZ, 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 | 7 | 104 | 0 | 41 |
| 2008 | 1 | — | 0 | 44 |
| 2009 | 1 | — | 0 | 81 |
| 2010 | 1 | — | 8 | 98 |
| 2011 | 1 | — | 0 | 127 |
| 2012 | 1 | — | 1 | 168 |
| 2013 | 0 | — | 0 | 274 |
| 2014 | 0 | — | 0 | 278 |
| 2015 | 0 | — | 0 | 636 |
| 2016 | 1 | — | 0 | 1,180 |
| 2017 | 2 | — | 0 | 477 |
| 2018 | 0 | — | 0 | 283 |
| 2019 | 0 | — | 0 | 532 |
| 2020 | 0 | — | 0 | 288 |
| 2021 | 0 | — | 0 | 216 |
| 2022 | 0 | — | 0 | 158 |
| 2023 | 0 | — | 1 | 164 |
| 2024 | 1 | — | 0 | 145 |
| 2025 | 1 | — | 0 | 193 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The RinglocB Constrained Liner is indicated for use as component of a total hip prosthesis in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular &ease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021728 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021728: Ringloc Constrained Liners II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021728
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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