510(k) · Cleared
ClearedCrossfire System 12 Acetabular Inserts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Cleared on Nov 19, 1999 as substantially equivalent to K974685 (Osteonics Corp., 1998) and 5 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1990. 18 later devices descend from it.
- Decided
- Nov 19, 1999
- Review
- 45 days
- Class
- Class II
- Product code
- LPH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 1 generation to K903362 (1990). 6 ancestors in all. 18 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK903362 Osteolock (TM) Acetabular CupHowmedica Corp. · 1990
- This deviceK993352 Crossfire System 12 Acetabular InsertsHowmedica Osteonics Corp. · 1999
- Descendant · cites it directly · 13 of its ownK111546 U2 Hip SystemUnited Orthopedic Corp. · 2011 · Recalled
- Descendant · 2 generations on · 7 of its ownK122185 U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013
- Descendant · 3 generations on · 3 of its ownK163441 Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017
- Descendant · 3 generations on · 3 of its ownK132455 U-Motion II PS+ CupUnited Orthopedic Corp. · 2013
- Descendant · 2 generations on · 3 of its ownK122504 Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation · 2012
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K111546U2 Hip SystemUnited Orthopedic Corp. · 2011 · cites it directly13descendants
- K122185U-Motion II Acetabular SystemUnited Orthopedic Corp. · 2013 · 2 generations on7descendants
- K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation · 2017 · 3 generations on3descendants
- K132455U-Motion II PS+ CupUnited Orthopedic Corp. · 2013 · 3 generations on3descendants
- K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation · 2012 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903362 | Osteolock (TM) Acetabular Cup | Howmedica Corp. | 1990 | — |
| 0 (this device) | K993352 | Crossfire System 12 Acetabular Inserts | Howmedica Osteonics Corp. | 1999 | — |
| +1 | K111546 | U2 Hip System | United Orthopedic Corp. | 2011 | 1 |
| +2 | K122185 | U-Motion II Acetabular System | United Orthopedic Corp. | 2013 | — |
| +3 | K163441 | Locking Cage, Full XPE Cup | United Orthopedic Corporation | 2017 | — |
| +3 | K132455 | U-Motion II PS+ Cup | United Orthopedic Corp. | 2013 | — |
| +2 | K122504 | Femoral Heads, 2.5 and 7.5 MM Neck Length | United Orthopedic Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 LPH? 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 LPH device
- #1 K233498 Stryker Orthopaedics Hip Systems Labeling Updatescore 24.3 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K974685 | Osteonics Polyethylene Acetabular ComponentsSummary page 1…tification . Osteonics Polyethylene Acetabular Inserts, fabricated from crosslinked polyethylene called "Crossfire", were determined Substantially Equivalent via 510(k) #K974685 on 12/16/97 (sponsor: Osteonics Corp.). Page i MAR-139-1933 19:59 P.83785 Additional Crossfire™ Acetabular Com… | 1998 |
| * | K903362 | Osteolock (TM) Acetabular CupSummary page 2…ssfire™ Acetabular Components 510(k) Summary . Howmedica System 12® Acetabular Inserts (non-Crossfire) were determined Substantially Equivalent as follows: via 510(k) #K903362. These were room air irradiated versions, previously cailed Osteolock inserts (sponsor: Howmedica Inc..). - via 510(k) #K951114… | 1990 |
| * | K951114 | System 12 P1 26MM Acetabular InsertSummary page 2…lly Equivalent as follows: via 510(k) #K903362. These were room air irradiated versions, previously cailed Osteolock inserts (sponsor: Howmedica Inc..). - via 510(k) #K951114. These were room air irradiated versions, specifically for the additional P1 26mm size. - via 510(k) #K951115. These were room a… | 1995 |
| * | K951115 | Howmedica Vitalock 22MM Acertabular Shell and System 12 InsertsSummary page 2…teolock inserts (sponsor: Howmedica Inc..). - via 510(k) #K951114. These were room air irradiated versions, specifically for the additional P1 26mm size. - via 510(k) #K951115. These were room air irradiated versiops, specifically for the additional 22mm sizes. - via 510(k) #K934060. These were Duration… | 1995 |
| * | K934060 | Howmedica (R) Acetabular Comp Pack/Manuf Meth ChangeSummary page 2…specifically for the additional P1 26mm size. - via 510(k) #K951115. These were room air irradiated versiops, specifically for the additional 22mm sizes. - via 510(k) #K934060. These were Duration® Stabilized versions. - via 510(k) #K963612. This submission allowed additional wear claims for the Durati… | 1995 |
| * | K963612 | Duration Stabilized UhmwpeSummary page 2…15. These were room air irradiated versiops, specifically for the additional 22mm sizes. - via 510(k) #K934060. These were Duration® Stabilized versions. - via 510(k) #K963612. This submission allowed additional wear claims for the Duration® Stabilized versions. Device Description The subject Crossfir… | 1997 |
What descends from it? (18)
See all 183 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 LPH devicesLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPH
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPH
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPH
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPH
6,163in 2025
MAUDE reports naming product code LPH, 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 | 10 | 116 | 16 | 509 |
| 2008 | 10 | 86 | 1 | 706 |
| 2009 | 3 | 112 | 2 | 1,156 |
| 2010 | 15 | 100 | 22 | 2,007 |
| 2011 | 16 | 110 | 26 | 3,320 |
| 2012 | 25 | 76 | 30 | 3,785 |
| 2013 | 11 | 135 | 9 | 5,002 |
| 2014 | 20 | 129 | 3 | 5,163 |
| 2015 | 18 | 111 | 1 | 5,830 |
| 2016 | 10 | 150 | 8 | 4,900 |
| 2017 | 12 | 121 | 14 | 5,312 |
| 2018 | 9 | 145 | 2 | 5,954 |
| 2019 | 22 | 164 | 8 | 7,130 |
| 2020 | 7 | 164 | 6 | 5,429 |
| 2021 | 8 | 410 | 4 | 5,978 |
| 2022 | 14 | 247 | 2 | 5,223 |
| 2023 | 10 | 111 | 2 | 5,345 |
| 2024 | 6 | 92 | 1 | 5,626 |
| 2025 | 12 | 153 | 4 | 6,163 |
| 2026 | 8 | 256 | 2 | — |
What is it indicated for?
The subject devices are single use components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows: . noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, . rheumatoid…
Read the full statement (103 words)
The subject devices are single use components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows:
. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
. rheumatoid arthritis,
. correction of functional deformity,
. revision procedures where other treatments or devices have failed, and
. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993352: Crossfire System 12 Acetabular Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993352
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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